The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic […]
A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in […]
Shots: Sinovent & SinoMab to receive $12M up front, ~$549M in development, regulatory & commercial milestone along with royalties on net sales of a product […]
Bioprocessing technologies company Repligen is acquiring Avitide, and its biologics purifying technology, in a $150 million cash and stock deal. Repligen said Avitide will help […]
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots […]
Rune Labs developed software that aggregates brain data, providing insights for clinical care and clinical research. Health systems are starting to adopt the technology, and […]
Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With […]
Shots: The P-IIIb ASCEND study will evaluate the clinical outcomes & safety of the higher doses of nusinersen in 135 patients aged 5-39yrs. with SMA […]
Dice Therapeutics raised $204 million from its IPO to support development of oral drugs that could compete against biologic drugs that are injected or infused. […]
The clinical trial failure of Theravance Biopharma’s most advanced internal program, a drug for a rare blood pressure disorder, is leading to a companywide restructuring. […]
Vanqua Bio aims to treat rare form of Parkinson’s disease by boosting activity of an enzyme that is deficient in patients who have a particular […]
The death occurred less than two weeks after Astellas Pharma reported that the patient developed liver problems after being dosed with the experimental gene therapy […]
If there was an AI solution in the Life Sciences field, able to represent a real opportunity in terms of Customer Engagement and Digital Transformation, […]
Shots: Nuformix is eligible to receive an up front, development milestone along with royalties when the net sales reaching $2.76M/annum Oxilio gets an exclusive license […]
Walking Fish Therapeutics is developing cell therapies from B cells, a type of immune cell that produces prodigious amounts of proteins. Cancer, autoimmune disease, and […]
AbbVie will take the lead on commercializing Regenxbio’s gene therapy in wet AMD and diabetic retinopathy. It’s AbbVie’s second major gene therapy deal this year, […]
Shots: Regenxbio to receive $370M up front in addition to ~$1.38B as development, regulatory and commercial milestones along with royalties on net sales of RGX-314 […]
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing […]
The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical […]
Biotech startup iECURE is based on work from the University of Pennsylvania scientist, who has been researching ways to use in vivo gene editing as […]
A-Alpha Bio’s technology analyzes millions of protein-protein interactions simultaneously, a capability that speeds up drug discovery research. Biotech industry partners are already using the technology […]
The cash deal brings to Sanofi the Kadmon Holdings drug Rezurock, which the FDA approved in July as a treatment for chronic graft versus host […]
Shots: AM-Pharma to receive $23.6M up front, $35.4M in milestones before regulatory submission and ~$230.4M upon submission, NHI price listing & sales milestone along with […]
Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also […]
A Phase 1/2 study of BioMarin Pharmaceutical’s gene therapy for phenylketonuria has been placed under a clinical hold after interim results from a preclinical study […]
Shots: Advent and GIC to acquire Sobi for ~$8B (SEK 69.4B) at $27.33/share (SEK 235) representing a premium of 34.5% to the closing price of […]
Shots: Dr. Reddy’s to receive $40M up front upon the closing of the transaction, followed by ~$40M milestones on E7777’s approval in CTCL and ~$70M […]
The FDA improved an Impel NeuroPharma migraine treatment, a nasal spray intended to bring pain relief more quickly than drugs administered in other ways. It […]
A Novartis drug intended to prevent organ rejection has failed to beat out the standard of care therapy in a Phase 2 study in kidney […]
A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical […]
Four patients dosed with an experimental Assembly Biosciences hepatitis B treatment developed high levels of liver enzymes, a sign of drug-induced liver toxicity. The biotech […]
The FDA’s review of a post-marketing study for Pfizer blockbuster anti-inflammatory drug Xeljanz found a higher risk of cardiovascular problems and cancer, and the agency […]
Five months after raising $55 million to back a new technology and a promising lead cancer immunotherapy, Asher Biotherapeutics has reeled in $108 million more. […]
Johnson & Johnson reported results from a mid-stage study in southern Africa showing just 25% efficacy for its HIV vaccine. J&J developed the HIV vaccine […]
Novartis was unsuccessful developing bimagrumab as a treatment for a rare muscle disorder, but additional tests showed encouraging results in fat reduction. Startup Versanis Bio […]
Before developing any stakeholder engagement plan, it is crucial to have a clear understanding of all the relevant individuals and groups your product or device […]
Tie-ups of candy makers and nutritional product companies into a single firm called Bettera has culminated in a $1 billion acquisition by Catalent. The global […]
Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the […]
Aaron Ferguson, COO and co-founder of Vytal Challenging the status quo is never easy. Neither is being the underdog. Startups face both of these challenges […]
Full FDA approval of Pfizer and BioNTech’s Covid-19 vaccine was the biggest news in a busy week for coronavirus vaccines, drugs, and diagnostics. Here’s a […]
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common […]
Shots: Wanchunbulin to receive $30M up front, $170M as regulatory and sales milestone & is eligible to receive $15M as equity investment at a pre-money […]
The royalty agreement with HealthCare Royalty Partners will support ADC Therapeutics’ plans to commercialize its newly approved cancer drug and develop the next one in […]
Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave […]
As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second […]
Chronic kidney disease patients who experience pruritus after dialysis can now get relief from the first FDA-approved treatment for the condition. Cara Therapeutics received the […]
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to […]
Shots: Genevant is eligible to receive ~$303M up front and milestone along with royalties on future product sales Takeda gets exclusive rights to use Genevant’s […]
Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the […]
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart […]
Vigil Neuroscience led the way with a $90 million round of funding, one of four biotech companies to close Series B financing rounds in the […]
An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant […]
Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic […]
Shots: The companies collaborated to evaluate the safety and preliminary efficacy of Werewolf’s WTX-124 as monothx. or in combination with Merck’s Keytruda (anti-PD-1 therapy) in […]
In announcing plans to offer Covid-19 booster shots, federal health officials cited declining vaccine efficacy shown by real-world studies. But the World Health Organization said […]
GlaxoSmithKline drug Jemperli is now FDA approved for treating solid tumors throughout the body as long as they have a particular genetic signature. Expanding the […]
Verily’s recent moves have signaled the company’s interest in supporting decentralized clinical trials and real-world studies. Now the life sciences subsidiary of Alphabet is bolstering […]
Gritstone bio is developing Covid-19 vaccines that use self-amplifying messenger RNA, which is intended to further boost the immune response compared to mRNA alone. The […]
For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen […]
FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. […]
Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the […]
FDA approval of a therapy that pairs drugs from Eisai and Merck allows the combination to become a first-line treatment for renal cell carcinoma. It’s […]
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited […]
With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social […]
Shots: Takeda will lead the development of FIN-524/TAK-524 to treat UC prior to the start of its clinical program & will leverage its expertise in […]
The pandemic made collaboration necessary between stakeholders that otherwise tend to be at odds with each other. But as partnerships grow, providers, payers and pharma […]
Following several legal battles and opposition from providers, CMS is proposing nixing the Most Favored Nation Model, which matches payments for Medicare Part B drugs […]
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an […]
The short answer is that cancer vaccines represent no silver bullet but, in combination with other immunotherapy and drug cocktails, can prove potent.
Identifying the most important & active digital experts in your space is just the first step of the engagement planning cycle. Because even within a […]
Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant […]
An AstraZeneca lupus drug has been awarded FDA approval for treating the most common form of the autoimmune disorder. The regulatory decision gives AstraZeneca a […]
Ipsen is shoring up its neuroscience pipeline via a deal that gives it the option to license drugs that Exicure is developing for Huntington’s disease […]
Of the 20 companies that went public in the last week of July, 11 of them represent some aspect of the life sciences. The tally […]
Icosavax’s research developing a vaccine for a virus that can lead to deadly respiratory infections in the very young and the very old has found […]
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational […]
Shots: The sNDA is based on the P-III JUPITER-06 study evaluating toripalimab + CT vs PBO + CT in 514 patients with locally advanced or […]
Ardelyx drug tenapanor was rejected by the FDA as a treatment for a complication experienced by chronic kidney disease patients. The regulatory decision came two […]
Eli Lilly is beginning a research alliance discovering and developing small molecules that stimulate immune responses against cancer. If drugs from the partnership reach the […]
Shots: Protagonist to receive ~ $900M as development & sales milestones along with $80M already received under the original agreement with royalty rates remain unchanged. […]
The engineered viruses used to deliver gene therapies can spark complications and they can’t be re-dosed. Ring Therapeutics says viruses that evolved with humans can […]
Shots: The companies will initiate P-I/II study evaluating the safety and preliminary efficacy of BBP-398 in combination with both Opdivo as dual therapy & Opdivo […]
Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its […]
The hedge fund SS&C Technologies Holdings will be the majority stakeholder, while the two payers will each hold a minority interest in the PBM, dubbed […]
AC Immune is bolstering the Parkinson’s disease portion of its drug pipeline with a deal to acquire a therapeutic vaccine that Affiris is developing for […]
Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities […]
“Very satisfied” is the consensus of KOLs who participate in our SkyBoard virtual advisory board events. But, from what KOLs tell us, there are also […]
Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary […]
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs […]
Adverum Biotechnologies still doesn’t know if its experimental gene therapy caused eye problems reported in April in one patient in its diabetic macular edema study. […]
Caribou Biosciences’ CRISPR approach to cell therapy sparked strong investor interest, enabling the clinical-stage biotech to upsize its IPO and raise $304 million in the […]
Arvinas’ early clinical data for its targeted protein degradation drug for breast cancer drew partnering interest from several companies. Pfizer beat them all with a […]
Legislators threaten to ban settlements where branded companies “pay” generics makers to “delay” market entry, while drugmakers say the current framework balances competition and innovation. […]
Seres Therapeutics’ ambitions to treat ulcerative colitis with a microbiome drug were dealt a setback as its experimental therapy failed in Phase 2 testing. The […]
The FDA has approved Bylvay, an Albireo Pharma drug that treats the severe itching experienced by patients with progressive familial intrahepatic cholestasis (PFIC). Prior to […]
Shots: Calliditas to receive $24M upfront and is eligible to receive ~$91M as regulatory and commercialization milestones along with royalties on net sales The companies […]
An amyotrophic lateral sclerosis drug from Amylyx Pharmaceuticals is being prepared for Phase 3 clinical testing on track to begin later this quarter. To support […]
Cancer drug developer Frontier Medicines already has a research partnership with AbbVie. Now the preclinical-stage biotech has raised $88.5 million for its own pipeline, including […]
An efficient way to create patient-focused educational materials is putting together a strategic group focused on consumers, which includes a medical expert, allied health professionals […]
A Cytokinetics drug in development for treating a rare heart disorder has promising Phase 2 data suggesting it could compete against a Bristol Myers Squibb […]
An intranasal Covid-19 vaccine candidate from Meissa Vaccines could offer advantages compared to injectable ones. The company is still in early clinical development but the […]
Research organizations can participate in ethical data sharing today by considering participants’ privacy and security and balancing the need to protect their commercial interests with […]
Digital health thought leader Mark Tarby, BrightInsight vice president of regulatory and quality management systems, shared his take on what the EU MDR means for […]
Vaxneuvance, a Merck pneumococcal vaccine, is now approved by the FDA. The intramuscular shot protects against 15 pneumococcal strains—five fewer than the 20 covered by […]
Cancer drug developer Erasca, whose mission is to “erase cancer,” has raised $300 million from its IPO. The clinical-stage biotech addresses a single elusive cancer […]
Shots: Under Dzuveo agreement, AcelRx to receive ~$55M as an up front and commercial milestones in addition to 35% to 45% revenue share on net […]
Shots: IRLAB to receive ~$363M, including $28M as up front and ~$335M as development, regulatory and commercial milestones along with royalties on WW net sales […]
Wugen, a biotech developing “off-the-shelf” natural killer and CAR T cell therapies, has raised $172 million in Series B financing. The company’s lead program has […]
Startup PAQ Therapeutics is developing drugs work like Pac Man, gobbling up components of a cell associated with disease. The biotech has closed $30 million […]
Eli Lilly has Protomer Technologies, a preclinical startup developing next-generation insulin that senses blood glucose levels and adjusts its activity accordingly. The technology could eliminate […]
By paying $125 million up front for rights to multiple sclerosis drug candidate orelabrutinib, Biogen secures a place among those companies trying to treat the […]
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on […]
The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not […]
Shots: Hutchmed receives $25M as milestones at 1st commercial sales of Orpathys in China & will receive fixed royalties of 30% based on all sales […]
Shots: InnoCare to receive $125M as up front & is eligible to receive ~ $812.5M as development & commercial milestones, following the achievement of definite […]
ProfoundBio is developing a type of targeted cancer therapy called antibody drug conjugates. As the biotech looks ahead to clinical trials, it has raised more […]
Novo Nordisk is paying $100 million up front to acquire an experimental Prothena drug being developed to treat heart problems stemming from a misfolded protein. […]
Over time, a variety of methods / approaches have been developed for the generation of viable therapeutic leads. These include the hybridoma technology, B-cell cloning, […]
The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, […]
A hemophilia A patient in a Sigilon Therapeutics clinical trial developed a well-known complication to treatments for the blood disorder. The potential problem for Sigilon […]
Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating […]
Who influences whom? Who’s connected to whom? Who collaborates with whom? These are some of the most important questions that should be answered when creating […]
Xilis is developing technology that creates a living model of a patient’s tumor, then applies artificial intelligence to determine the best drug or drug combinations […]
The drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the […]
Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence […]
A NeRRE Therapeutics drug that failed a clinical trial for refractory or unexplained chronic cough is getting a second shot as a potential treatment for […]
Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making […]
Provention Bio needs to show the FDA that the drug substance produced from its contract manufacturer is comparable to the Eli Lilly-made drug substance that […]
Shots: Abbisko to receive upfront, milestones and royalties on net sales of the therapy & hold the rights for all other countries & indications. Sperogenix […]
Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. […]
GlaxoSmithKline is paying Alector $700 million up front to share in the development of the biotech’s two lead drugs, which offer potentially broad application in […]
Shots: Denovo has licensed the global rights for idalopirdine including all rights to develop, manufacture and commercialize idalopirdine for all indications. Lundbeck gets an option […]
Shots: Kaken to receive an up front in cash and is eligible to receive milestones and royalties on the sales of the product. Almirall plans […]
Acumen Pharmaceuticals’ IPO raised $160 million to fund clinical development of its Alzheimer’s disease drug candidate. Though that drug goes after the same target as […]
Despite mounting court and legislative scrutiny of pharmacy and prescription benefit manager practices, Amazon has chosen to throw its hat into the discount pharmacy ring. […]
Shots: Orchard to receive $17.5M up front including $10M in cash & $7.5M as equity investment at a premium to Orchard’s share and is also […]
Shots: Beam to receive $50M up front and $25M as near-term milestones & will be eligible to receive other milestones along with royalties on sales, […]
Fresh off its first FDA approval, Apellis Pharmaceuticals is teaming up with Beam Therapeutics, a partnership that will use Beam’s base-editing technology to develop new […]
Led by former Viela Bio CEO Bing Yao, ArriVent Biopharma secures rights to drugs from emerging biotech hubs, then develops them for Western markets. The […]
Pardes Biosciences advanced from concept to drug candidate in less than nine months. The preclinical biotech is developing an oral antiviral for Covid-19 and other […]
Walmart struck a deal with Novo Nordisk to offer a heavily discounted, private-label version of its fast-acting analog insulin. But it still doesn’t solve the […]
Sanofi, already a global leader in vaccine production, has formed a new division that will focus exclusively on developing messenger RNA vaccines. The pharmaceutical giant […]
Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomal, a drug developed to treat the rare Niemann-Pick disease type C. The […]
Intellia Therapeutics has early clinical trial data showing that its CRISPR-based therapy for a rare disease can edit genes inside the body safely and effectively. […]
The FDA has granted emergency use authorization to a Roche antibody as a treatment for hyperinflammation in patients hospitalized with severe Covid-19. The drug, Actemra, […]
Systems Oncology has used its its artificial intelligence to discover small molecules in development under partnerships with large pharma companies. The R&D of the company, […]
Health Union, the leader in building online health solutions for people living with chronic conditions, today announced that it has acquired WEGO Health, the world’s […]
Shots: CytoReason reports the initiation of a project with Sanofi by utilizing its cell-centered models and deconvolution techniques to counsel mechanistic insights for each asthma […]
Lyell Immunopharma and Verve Therapeutics are still preclinical, but they’re bring novel genetic approaches to the treatment of cancer and cardiovascular disease. Now the two […]
A Covid-19 vaccine candidate based on messenger RNA technology from CureVac is showing 47% efficacy according to an interim analysis of a pivotal study. The […]
Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license […]
Mallinckrodt Pharmaceuticals received FDA approval for its engineered skin product, StrataGraft, a treatment for serious thermal burns. The product is the latest to be reviewed […]
The health technology company offers a platform that enables clinicians to more quickly and accurately complete specialty drug enrollment processes and communicate with specialty pharmacies. […]
Shots: Linnaeus will conduct 6 additional P-II cohorts evaluating LNS8801 + Keytruda in several cancer indications while the companies are currently evaluating the combination in […]
A Sage Therapeutics depression drug that failed a pivotal study in 2019 has positive preliminary results from a new Phase 3 clinical trial, but the […]
GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target […]
Novavax reported that its Covid-19 vaccine was 100% effective at protecting against moderate and severe disease and 90.4% effective overall. The vaccine is seen as […]
The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the […]
Shots: Verona Pharma to receive $40M including $25M upfront cash and $15M equity interest in Nuance Biotech, and is eligible to receive ~$179M in milestones […]
Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are […]
Senda Biosciences is developing drugs based on an understanding of intersystems biology—the way that humans interact with bacteria and plants. The startup, founded by Flagship […]
The clinical trial arena is changing rapidly, driven largely by the acceleration of telehealth usage and the potential provided by new data solutions. Panelists at […]
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. CIOs and […]
Shots: Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA […]
Minority groups get left out of clinical trials and studies for many reasons, including lack of access, awareness and trust in the healthcare system. But, […]
The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are […]
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According […]
Shots: The discontinuation is based on Janssen’s review of all available cusatuzumab data and in consideration of the evolving SOC for AML. Argenx regain its […]
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed […]
Cancer drug developer Merus has encouraging early results indicating its drug can address several different types of tumors characterized by NRG1, a rare gene fusion. […]
Cancer is one of the leading causes of death worldwide, accounting for an estimated 0.6 million deaths in 2020, in the US alone. The World […]
Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup […]
Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans […]
Join us for an interactive, one-day digital event, where VPs, Directors and Heads of Supply Chain and Logistics come together to share their experiences, brainstorm […]
J+D Forecasting has worked with one of Europe’s largest, leading biotechnology pioneers, helping to facilitate better, more collaborative forecasting for hundreds of colleagues across the continent. […]
The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of […]
Shots: The first patient has enrolled in P-III TETON study to evaluate the safety and efficacy of treprostinil (Inhalation Solution) or PBO in a ratio […]
Novartis reported Phase 3 study results for a targeted radiation therapy showing that treatment helped patients with advanced prostate cancer live longer. The company will […]
Auris Medical has acquired Trasir Therapeutics, a startup developing technology that expands the delivery of RNA medicines to tissues beyond the liver. Going forward, Auris […]
The FDA has approved Brexafemme, a Scynexis antifungal drug, for treating vaginal yeast infections. The drug is the biotech’s first FDA-approved product and it also […]
MorphoSys is acquiring Constellation Pharmaceuticals and its late-stage myelofibrosis drug in a deal that values the epigenetics biotech at $1.7 billion. Germany-based MorphoSys will finance […]
Who will benefit? New and aspiring marketers and those wanting to refresh their marketing thinking and be fitter to handle today’s healthcare environment. Topics covered […]
Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, […]
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate […]
Shots: Kyowa Kirin to receive ~$400M up front and an additional ~$850M as milestones along with royalties on future global sales. Both companies will share […]
Three life science companies went public in the last full week of May. The biggest IPO belonged to Centessa Pharmaceuticals, a company that raised $330 […]
FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS […]
FDA authorization of the Covid-19 antibody drug from Vir Biotechnology and GlaxoSmithKline adds a third antibody drug for treating early cases of the disease that […]
For the second time in the span of one year, a group of insurers has filed a lawsuit against CVS alleging it overcharged them for […]
Myovant hormonal drug Myfembree has won FDA approval as a treatment for uterine fibroid bleeding. The regulatory decision clears the way for the pill to […]
The FDA placed a clinical hold on a Larimar Therapeutics program for Friedreich’s ataxia after monkeys died in tests of the fusion protein. In addition […]
Earlier this year, Healthware Group and Plexus Ventures formed an alliance to structure deals for the pharmaceutical industry in the development and commercialization of Digital Therapeutic (DTx) products. Given the […]
IQVIA is paying nearly $200 million to purchase a Myriad Genetics subsidiary that provides pharmaceutical contract services , a deal that will put the new […]
Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans […]
After decades of struggling with poor public perception, the pharma industry has an opportunity to generate stronger connections with consumers than ever thanks to the […]
An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive […]
Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. […]
CVS has launched a new clinical trials services business that will help drug companies and contract research organizations recruit clinical trial volunteers. The new business […]
Biogen is reaching across the Charles River, striking up a gene therapy manufacturing alliance with synthetic biology firm Ginkgo Bioworks. Ginkgo will use its technology […]
Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type […]
Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping […]
BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies […]
New investment company eureKARE aims to find promising microbiome and synthetic biology research in Europe and create new companies around that science. EureKARE has three […]
Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on […]
Shots: Mestag to receive option fees, milestones, royalties and will deploy its specialist fibroblast sub-population biology platform and state-of-the-art data analytics to identify novel therapeutic […]
Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific […]
Shots: Fujifilm and Opsis to receive $30M up front and ~$40M as R&D and part of manufacturing funding for the development of 3 programs. The […]
The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion […]
Sanofi and GlaxoSmithKline reported positive preliminary Phase 2 data for their Covid-19 vaccine. Though several vaccines have been authorized, the companies say that their vaccine’s […]
Vera Therapeutics raised $47.9 million from its IPO to continue clinical development of its lead asset, a potential treatment for the kidney disease IgA nephropathy. […]
In a month where GoodRx’s stock has been trading below IPO levels, the startup’s leadership says Amazon Pharmacy still isn’t a threat. Citing third-party data, the […]
A Biogen gene therapy for a rare, inherited eye disorder that leads to blindness has failed a key clinical trial. The preliminary results are the […]
Shots: The interim data from 18 patients out of 20 in P-II trial evaluating the safety, tolerability, and efficacy of MS1819 (700/1200/2240 mg, qd, for […]
Interline Therapeutics has technology that shows how proteins interact as communities, paving the way for the discovery of new drugs. CEO Zachary Sweeney, a Denali […]
Heron Therapeutics is positioning its drug, Zynrelef, as a way to help patients avoid addictive opioid painkillers following surgery. The extended-release formulation offers analgesic effects […]
As the push towards Digital HCP engagement intensifies, we have seen an increase in the number of requests for identifying Digital KOLs to help author […]
Shots: Biogen’s decision of acquisition of TMS-007 based on the safety, imaging, and clinical outcome data from the P-IIa study which showed positive impacts on […]
Biogen paid $18 million to acquire a drug that TMS Co. of Japan tested in patients with acute ischemic stroke. The acquisition follows the report […]
Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking […]
Shots: Nanobiotix to receive a $20M up front and is eligible to receive ~$220 M as contingent payments and milestones along with royalties on net […]
Shots: Autobahn acquires global IP, development, and regulatory rights to ASP3652 to strengthen its brain-targeting chemistry platform. The addition of ASP3652 will accelerate the delivery […]
Ginkgo Bioworks, a company whose cell engineering work can be found in products ranging from food ingredients to vaccines, is going public in a SPAC […]
The companies are supporting 12 culturally competent healthcare startups in a new accelerator. Two of them will get up to $200,000 in grant funding.
The FDA has expanded emergency use of the Pfizer/BioNTech Covid-19 vaccine to include children 12 to 15 years of age. Meanwhile, the regulator is planning […]
Incubated by Flagship Pioneering, biotech firm Laronde is developing endless RNA, or eRNA, a new class of medicines that goes beyond messenger RNA-based therapies. Flagship […]
The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies […]
Three biotechs IPOs priced this week while one gene therapy developer postponed its plans. The biggest IPO belongs to Talaris Therapeutics, a company developing a […]
Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will […]
Shots: BeiGene and Asieris collaborate to evaluate the safety and efficacy of APL-1202 + tislelizumab as neoadjuvant therapy in patients with MIBC. APL-1202 has been […]
Becton Dickinson is known worldwide for its diabetes products. Now the medical technologies giant plans to spin off its diabetes care business as a separate, […]
Dyno Therapeutics’ technology for designing viral vectors that deliver gene therapies has led to partnerships with Novartis, Sarepta Therapeutics, and Roche. With the Series A […]
Shots: ProQR is eligible to receive ~$115M up front and milestone along with royalties on the sales of any resulting products during the royalty term […]
Cell therapy manufacturing is currently a manual, multi-step process that takes weeks. Startup Cellares, which is developing a system that automates the process and makes […]
Glasgow, UK – (March 29, 2021) – Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based […]
Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The […]
Vaccitech and Werewolf Therapeutics joined the public markets, raising a combined $230 million. The vaccine developer and the cancer immunotherapy biotech will apply the IPO […]
The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches […]
Capsule, an online pharmacy startup that offers same-day prescription delivery, raised $300 million in funding. It plans to use the funds to build out an […]
Adverum Biotechnologies reported that a diabetic macular edema patient treated with the biotech’s experimental gene therapy developed complications, including blindness, in the treated eye. The […]
Change is coming in the digital marketing world whether you’re ready or not. New challenges are presented for marketers as privacy measures tighten and we say […]
Boundless Bio’s research has uncovered a previously unknown driver of cancer growth and drug resistance. With $105 million in Series B financing, the biotech is […]
Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, […]
Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a […]
Several companies are developing immunotherapies targeting the “don’t eat me” cancer protein CD47. Arch Oncology, which is developing drugs with features that could set them […]
Shots: Esperion to receive $30M up front, ~$175M as sales milestones along with royalties from 5-20% on sales in the territory. Daiichi Sankyo will get […]
A uniQure gene therapy for hemophilia B that has been under a clinical hold for four months can now resume testing. The hold was lifted […]
With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical […]
Alnylam Pharmaceuticals has filed for FDA approval of vutrisiran, which could become the biotech’s fourth drug that works by RNA interference. Meanwhile the company is […]
Covid-19 showed how technology can upend the old ways of clinical trials. Panelists at MedCity’s INVEST conference said it’s highlighting the importance of improving clinical […]
The FDA approved GlaxoSmithKlie drug dostarlimab (Jemperli) for endometrial cancer that carries a particular genetic signature. The immunotherapy now joins Merck’s Keytruda as the checkpoint […]
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