From banking to biotech – Renée Aguiar-Lucander’s unique path in science
RenÃe Aguiar-Lucander, CEO of Calliditas, is driving the advancement and launch of TARPEYO â the companyâs medication targeting rare disease IgA nephropathy. We spoke with […]
RenÃe Aguiar-Lucander, CEO of Calliditas, is driving the advancement and launch of TARPEYO â the companyâs medication targeting rare disease IgA nephropathy. We spoke with […]
Saurabh Tripathi, former CFO of Highmark Health, assumed the role on Monday.
Shots: G1 Therapeutics & Pepper Bio have entered into a global licensing agreement (except the Asia-Pacific region) for lerociclib, entering into P-II clinical evaluations, covering […]
Deal would resolve tens of thousands of lawsuits alleging company’s baby powder causes ovarian cancer Johnson & Johnson is moving forward with a $6.475bn proposed […]
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more […]
Shots: Harmony Biosciences has reported the acquisition of Epygenix Therapeutics to expand its late-stage CNS pipeline by adding rare epilepsy franchise The acquisition brings clemizole […]
Josh Hirshenhorn (Sales Representative, Rees Scientific) explains current challenges faced by pharmaceutical and biotech companies and how Rees’ continuous monitoring systems offer solutions.
GSK looks like it is starting to show the benefit of a revamp of its business under chief executive Emma Walmsley, with recent product launches […]
Shots: Jacobio highlighted the data from the P-II registrational trial evaluating glecirasib (KRAS G12C inhibitor) alone for NSCLC at the April ASCO Plenary Series The […]
Shots: The P-IIb study assesses the safety & efficacy of enobosarm (3mg, 6mg) or PBO to treat conserving muscle & augment fat loss among patients […]
Polish drug delivery company Biotts says it has demonstrated delivery of insulin across the skin for the first time without the use of an injection […]
The progressive neurological condition affects more than six million people worldwide
Bladder cancer, including papillary tumours, is the ninth most common cancer type worldwide
The US Federal Trade Commission (FTC) has expanded its campaign against so-called ‘junk’ patents intended to extend market exclusivity and block generic rivals. The financial […]
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it will launch a pilot programme in the coming weeks to see how it […]
A petition filed in the Supreme Court seeks the formation of a medical panel from AIIMS, Delhi to study Covishield’s side effects. It demands supervision […]
For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and […]
Shots: PeptiDream has expanded its partnership with Novartis previously signed in 2019 for the discovery of peptides to be used as peptide-drug conjugate The partnership […]
Following AstraZeneca’s acknowledgment of a rare side effect associated with its COVID-19 vaccine, known as Covishield in India, the UK pharmaceutical giant extended sympathy to […]
MYRBETRIQ GRANULES (mirabegron) Apgdi Patent: 7,982,049 Expiration: May 4, 2024 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business […]
This chart shows the drugs with the most patents in Japan. Patents must be filed in each country (or, in some cases regional patent office) […]
By Andrew Velzen — On January 19, 2024, Palworld launched into early access on Xbox and Windows. To say it was an overnight success is […]
When Barbra Streisand posted a comment on social media about the actress Melissa McCarthy, it prompted a public conversation.
Key areas to invest include manufacturing process improvements, quality management, and AI.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Proteins are the workhorses of life. Organisms use them as building blocks, receptors, processors, couriers and catalysts. A protein’s structure is critical to its function. […]
New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to […]
The parents of a woman allegedly deceased after receiving the Covishield vaccine plan to file a case against the Serum Institute of India (SII). This […]
Meeta B. Kratz (Global Vice President, Product Management & Marketing, Lonza Capsule and Health Ingredients) talks about Lonza’s future and how that works in tandem […]
On Wednesday, hospitals will no longer be required to report COVID-19 admissions, capacity or occupancy data to the federal government.
On Wednesday, hospitals will no longer be required to report COVID-19 admissions, capacity or occupancy data to the federal government.
Scientists report significant progress in cultivating nephron progenitor cells (NPCs), the cells destined to form the kidney’s filtration system, the nephrons. NPCs hold immense promise […]
The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for […]
Learn about the forum we hosted for stakeholders interested in the Consumer Health Literacy or Health Professional Education Grant Opportunity.
Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis, which typically takes from minutes to hours to acquire measurement. [the […]
New Drug Designations – March 2024 Shots: PharmaShots’ designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and […]
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA […]
From resurrecting an extinct species to improving regenerative medicines with plant-based materials, these biotechs are on the leading edge of science.
Vertex Pharmaceuticals is having a moment. Several moments, in fact. Dr. David Altshuler, chief scientific officer, Vertex Pharmaceuticals Permission granted by Vertex Months after […]
[Federal Register Volume 89, (Tuesday, April 30, 2024)] [Notice] [Pages 34273-34274] Notice of Alleged Safety and Health Hazards (OSHA-7 Form); Extension of the Office of […]
[Federal Register Volume 89, (Tuesday, April 30, 2024)] [Notice] [Pages 34274-34276] Hazardous Energy Control Standard (Lockout/Tagout); Extension of the Office of Management and Budget’s (OMB) […]
[Federal Register Volume 89, (Tuesday, April 30, 2024)] [Notice] [Pages 34271-34273] CSA Group Testing & Certification Inc.: Applications for Expansion of Recognition
[Federal Register Volume 89, (Tuesday, April 30, 2024)] [Notice] [Pages 34271] Agency Information Collection Activities; Submission for OMB Review; Comment Request; Mechanical Power Presses Standard
The World Health Organization (WHO) has published a new draft guidance on mitigating nitrosamine contamination in pharmaceutical products. Manufacturers of excipients and APIs should be […]
Shots: The US FDA has approved Xolremdi (mavorixafor) capsules for treating WHIM syndrome patients (12yrs. & above) and granted a Rare Pediatric Disease Priority Review […]
Shots: Bayer and Evotec have shifted the aim of their strategic agreement to develop precision therapeutics for addressing cardiovascular diseases (CVDs) The partnership will employ […]
Yesterday (April 29), Lonza, a global partner in the pharmaceutical, biotech, and nutraceutical sectors, announced the introduction of its AI-enabled Route Scouting Service (RSS).
Owlstone Medical, a global leader in Breath Biopsy for early disease detection and precision medicine, has announced a funding to the tune of $6.5 million.
In the heart of Montreal sits the non-profit organization Centech, a place that supports projects and startups with high growth potential â from conception right […]
Owlstone Medical, a global leader in Breath Biopsy for early disease detection and precision medicine, has announced a funding to the tune of $6.5 million.
Shots: ONO has signed a definitive merger agreement with Deciphera to enhance its oncology portfolio and expand its presence across the US & the EU, […]
GPT-4 is trained to offer eye-related advice, diagnosis and management suggestions
An estimated 50% of human genes, mostly active in the liver, follow a circadian cycle
Shots: The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization […]
California has said it will start selling its own generic version of overdose reversal agent naloxone in another example of the use of government-level purchasing […]
Sanofi India has launched its diabetes drug Soliqua in India, a once-daily injectable combination drug containing insulin and GLP-1 receptor agonist lixisenatide. The medication is […]
Prime Medicine has been given the go-ahead by the FDA for the first human trial of its prime editing technology, which promises to deliver one-shot […]
Shots: The P-III (STRIDE-10) trial assessed the immunogenicity, tolerability and safety of V116 vs PPSV23 in adults (n=1,484, 50yrs. & above) not receiving pneumococcal vaccine […]
Shots: The US FDA has approved Esprit BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System) intended for chronic limb-threatening ischemia (CLTI) below-the-knee (BTK) The […]
In another setback for the pharma industry, a US federal judge has rejected a bid to overturn the Medicare pricing negotiation brought by Bristol-Myers Squibb […]
Annual Drug Patent Expirations for DURYSTA Durysta is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. […]
Annual Drug Patent Expirations for OTEZLA Otezla is a drug marketed by Amgen Inc and is included in one NDA. It is available from one […]
Annual Drug Patent Expirations for LUTATHERA Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA. It is available from […]
Annual Drug Patent Expirations for ERLEADA Erleada is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one […]
Annual Drug Patent Expirations for TAVNEOS Tavneos is a drug marketed by Chemocentryx and is included in one NDA. It is available from one supplier. […]
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to […]
The non-profit initiative puts collaboration at the forefront as it tackles the challenges surrounding recycling primary pharmaceutical packaging.
The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities […]
Explore how Rentschler Biopharma duels biopharmaceutical innovation, spanning from pioneering biological products to cutting-edge cell and gene therapies
At an annual meeting of the USA-India Chamber of Commerce in Boston, Shanghvi told a gathering of leading multinational drug makers about the “clear positive […]
India enforced ‘Schedule M’ for drug manufacturers, emphasizing quality, recall systems. Companies must comply with strict rules on hygiene, audits, and reporting defects to DCGI […]
Scientists say that an experimental monoclonal antibody drug called mAb43 appears to prevent and reverse the onset of clinical type 1 diabetes in mice, and […]
Bill Humphries (CEO, Alcami) dives into an overview of Alcami’s capabilities and how they value their client’s innovations.
Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light […]
The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. The […]
Clinical Trials Day is celebrated on May 20, in recognition of what is often considered the start of the first randomized clinical trial.
Shots: Angela Cacace Sr. VP, of Neuroscience and Platform Biology at Arvinas, shares insights from the preclinical trials evaluating ARV-102 for treatment of neurodegenerative diseases and dosing […]
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
Researchers have reported a novel universal fungal identification method called Analysis of whole GEnome (AGE) for “the first-time demonstration of the identification potential of sequences […]
Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal […]
Michelle Werner shares how the lessons from her resumé — and personal experience — are driving her work with novel therapeutics.
The company’s schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.
[Federal Register Volume 89, (Monday, April 29, 2024)] [Notice] [Pages 33399-33400] Safe and Sound Campaign; Revision of the Office of Management and Budget’s (OMB) Approval […]
[Federal Register Volume 89, (Monday, April 29, 2024)] [Notice] [Pages 33398-33399] Maritime Advisory Committee on Occupational Safety and Health (MACOSH): Notice of Meeting
The Cell and Gene Therapy Catapult (CGT Catapult) has appointed three new Non-Executive Directors to its board. This supports the organisation’s mission to advance the industry […]
Response Pharmaceuticals, Inc., has unveiled significant findings from its Phase 1b clinical trial of RDX-002, signaling a potential breakthrough in combatting antipsychotic-induced weight gain (AIWG).
OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug […]
A significant milestone has been reached by Olden Labs as it steps into the limelight revealing its refreshing approach to animal research.
Mere months after announcing a partnership to develop digital support tools for cancer patients, Huma Therapeutics and Merck KGaA have launched their first app in […]
The method has the potential to be used to deliver RNA to the bloodstream for a range of diseases
The new process makes generating active pharmaceutical ingredients quicker and easier
UK startup George Medicines has named Mark Mallon as its new chief executive, who will oversee the company as it tries to get its triple […]
GNC and the Vitamin Shoppe are redesigning displays and taking other steps to appeal to people who are taking or are interested in drugs like […]
Johnson & Johnson’s Rybrevant is on the brink of EU approval as a treatment for a subset of patients with newly diagnosed EGFR-positive lung cancer, […]
Pfizer has said it will launch its just-approved haemophilia B gene therapy Beqvez with a warranty programme that will provide “greater certainty” to payers, after […]
Shots: Zoetis has signed a definitive agreement with Phibro Animal Health under which Phibro will acquire the company’s medicated feed additive (MFA) product portfolio, some […]
Glenmark Pharmaceuticals received USFDA approval for generic Acetaminophen and Ibuprofen tablets. The product, a version of Advil Dual Action, will be distributed by Glenmark Therapeutics […]
For many years, orphan drugs for rare diseases have been a draw for pharma companies, offering high prices, swift regulatory reviews and often extended marketing […]
Rare kidney diseases are a group of conditions, with at least 150 different disorders falling into this category. Kidney disorders are known to have a […]
This chart shows the pharmaceutical companies with the most gas dosed drugs. For a different perspective, see the most popular dosage types. The companies with […]
By Kevin E. Noonan — Over the past year suspended Federal CIrcuit Judge Pauline Newman’s lawsuit (see “Judge Newman and the On-Going Attempts to Remove […]
Exclusive: ‘Distressing’ scarcity sowing uncertainty among 400,000 with type 1 diabetes, experts warn People with type 1 diabetes are being forced to endure the “stress […]
Despite an arsenal of drugs, many Americans are still unaware of their infections until it’s too late. A Biden initiative languishes without Congressional approval.
This chart shows the pharmaceutical companies with the most spray dosed drugs. For a different perspective, see the most popular dosage types. The companies with […]
Doctors say patients come with specific queries regarding weight-loss drugs, which have become both the first preference and the last resort for some. “I would […]
Documents show officials were told blood plasma harvested from US convicts was contaminated with viruses • Read more: the true story of the UK infected […]
Over the past decade, India has seen significant improvements in its clinical trial landscape, with a 15-18% growth in phase two and three trials. This […]
High temperatures this week have left people sweltering and challenged businesses that need to keep their products cool.
SK pharmteco, a CDMO, will manufacture, test, and release Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy from Ferring Pharmaceuticals for treating bladder cancer.
Annual Drug Patent Expirations for DROSPIRENONE Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan […]
This chart shows the drugs with the most patents in South Africa. Patents must be filed in each country (or, in some cases regional patent […]
Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from […]
Annual Drug Patent Expirations for XOSPATA Xospata is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. […]
Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from […]
The virtual care giant’s earnings were dragged by flagging growth in its BetterHelp segment, which suffered an 11% drop in paying users year over year.
The collaboration will combine N4’s nanoparticle delivery system with SRI’s molecular guidance system.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Important Addresses for Regulatory Submissions
Therapeutic Biologics Applications (BLA)
A tidal wave of questions floats the need for more upstream automation.
How physicians interpret information about prescription drugs in scientific publications vs. promotional pieces
Readers respond to a letter which said that MDMA is not helpful in mental health care Rachel McNulty (Letters, 19 April) is right to emphasise […]
The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency […]
A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This […]
“approval [of Pyzchiva® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that […]
This week PharmaShots’ news was all about the updates on Regulatory, Clinical Trials, Pharma, Animal Health & MedTech. Check out our full report below: […]
Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development […]
AbbVie has revealed positive topline results from the first head-to-head trial in atopic dermatitis assessing RINVOQ® (upadacitinib) at a starting dose of 15mg daily versus […]
The 50th biosimilar approval milestone also reflects our strategic approach to biosimilars, as outlined in the FDA’s Biosimilars Action Plan.
Dr. Jeremy Levin, CEO of Ovid Therapeutics, explains how scientific advances have converged to create a new era of drug development potential.
In an extensive and enlightening chat with Prasad Rajeev, the CEO of LGM Pharma, OSP gained profound insights into the company’s trajectory within the pharmaceutical […]
Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional […]
Chemists at ETH Zurich have developed a new computer process that enables the generation of active pharmaceutical ingredients at speed, based on a protein’s three-dimensional […]
The new method could help to prevent severe side effects caused by enantiomer drugs
The paper identifies the roles and differences between LARP4A and LARP4B in sarcoma and carcinoma cancers
Shots: Vistagen reports P-IIa study (n=10) results, PH15 (1.6µg) shown statistically significant improvement in reaction time vs PBO & caffeine (p<0.001) in sleep-deprived participants at […]
In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA […]
Shots: Compass received US FDA’s FTD for CTX-009 with paclitaxel to treat metastatic or locally advanced BTC patients that have been previously treated Patients in […]
Shots: Regeneron and Mammoth signed a collaboration to develop and commercialize in vivo CRISPR-based gene editing therapies by using Regeneron’s AAV and antibody engineering and […]
Shots: Onconic’s JAQBO (zastaprazan citrate) received Korea’s MFDS approval, based on comprehensive data of P-III study from 28 sites of Korea presented at UEG in […]
[![topiramate structure](https://www.DrugPatentWatch.com/img/drug-structure/topiramate.png)](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]
Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one […]
Annual Drug Patent Expirations for OGSIVEO Ogsiveo is a drug marketed by Springworks and is included in one NDA. It is available from one supplier. […]
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Luxembourg. SPCs are used in European Union and select others to […]
Webinar Date/Time: Wed, May 22, 2024 11:00 AM EDT
A multicenter study has identified a potential new treatment for acute heart failure, a leading cause of hospitalization and death.
While female KMPs in the financial services sector were all professional leaders, in pharma, they were promoters, according to data from FY23 collated for ET […]
While female KMPs in the financial services sector were all professional leaders, in pharma, they were promoters, according to data from FY23 collated for ET […]
At present there is no separate pricing framework followed for medical devices. The government has been using the same framework which was created for drugs […]
At present there is no separate pricing framework followed for medical devices. The government has been using the same framework which was created for drugs […]
Peptides, proteins, and the risks of cardiac arrythmias: a CDER study suggests that the human Thorough QT study is not needed for products comprised of […]
The majority of PMCs/PMRs are proceeding according to schedule.
A study has determined that for biologics subject to multiple stresses during bioprocessing and manufacturing, “exposure to air-liquid interfacial dilatational stress is the predominant mechanism […]
The nonprofit is transferring ownership of two Caritas Clinics and shutting one down.
Machines can learn not only to make predictions, but also to handle causal relationships. An international research team shows how this could make therapies safer, […]
Researchers discovered that more than 300 liver genes are under circadian control: Circadian variations affect how much of a drug is available and how effectively […]
YouTube URL: https://youtu.be/8YVnXlr4Kgo Video Thumbnail Image:
Wuxi AppTec says recent allegations made by the US government that it has shared clients’ data with Beijing without consent are âmisleadingâ and âinaccurateâ.
Considering current developments in Alzheimer’s drugs, a US expert has predicted that the industry should “be prepared for more complex biological therapies that require intravenous […]
Shots: RNAi therapeutics are innovative medications that enable rapid identification of specific inhibitors of disease targets across a wide range of molecule classes. Several biopharma […]
A recent Deloitte report revealed that 36% of healthcare product launches fell short of achieving 80% of their sales targets within the first two years.
The Pharmacy Compounding Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to compounding drugs for human use and, as required, […]
From popular weight loss drugs to lifesaving cancer therapies, recent pharma deals show the industry is doubling down on manufacturing capacity to meet demand.
Research on the global pharmaceutical parenteral packaging market by InsightAce Analytic Pvt. Ltd. has predicted that the sector will value $18.85 billion by 2031. This is aligned […]
Shots: Labcorp won Invitae’s auction bid, in the sale process under US Bankruptcy Code Section 363 Following the auction, LabCorp will acquire all assets for […]
Shots: Atom Bioscience initiated patient enrolment in the US for a P-IIb/III study of ABP-671 in oral formulation to treat Chronic Gout P-IIb/III study (n=580) […]
CMTX1 is the second most common form of the rare peripheral neuropathy disease
The tool will help people find out about clinical trials for myeloma, MGUS, SMM and AL amyloidosis
Exclusive: MSF calls for transparency after its bill for a trial of TB treatment came to a fraction of the billions claimed by pharmaceutical companies […]
Last month, OSP was excited to write about One2Treat, a progressive startup specializing in digital health solutions, which has launched a forward-thinking approach aimed at […]
Facts and common misconceptions about some of America’s most widely used drugs.
Nestle India and Dr. Reddy’s form a joint venture to introduce new nutraceutical brands in India. The collaboration merges health solutions and commercial capabilities to […]
Nestle India and Dr. Reddy’s form a joint venture to introduce new nutraceutical brands in India. The collaboration merges health solutions and commercial capabilities to […]
Shots: CureVac announced initiation of P-I part of P-I/II study to evaluate influenza A (H5N1) pre-pandemic vaccine (up to 5 dose levels vs PBO) in […]
Shots: US FDA granted BTD designation to Blue Arbor’s RESTORE Neuromuscular Interface System and accepted for Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot […]
Shots: The MHRA has granted marketing authorization to Ascendis’ Yorvipath (Palopegteriparatide) for the treatment of adults with chronic hypoparathyroidism, along with ODD (10 yrs. market […]
By Kevin E. Noonan — The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. […]
Annual Drug Patent Expirations for AYVAKIT Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. It is available from one […]
Annual Drug Patent Expirations for LYBALVI Lybalvi is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one […]
Annual Drug Patent Expirations for SUNLENCA Sunlenca is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from […]
[![topiramate structure](https://www.DrugPatentWatch.com/img/drug-structure/topiramate.png)](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]
Annual Drug Patent Expirations for PROBUPHINE Probuphine is a drug marketed by Titan Pharms and is included in one NDA. There is one patent protecting […]
Annual Drug Patent Expirations for NEXLIZET Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. It is available from […]
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to […]
People who take acid-reducing drugs may have a higher risk of migraine and other severe headache than people who do not take these medications, according […]
To improve chemotherapy dosing, engineers designed CLAUDIA, a way to continuously measure how much drug is in a patient’s system during hours-long infusion.
Pivmecillinam, which has been used in Europe for decades, will become available next year to women 18 and older.
Conditions such as diabetes, heart attack and vascular diseases commonly diagnosed in people with spinal cord injuries can be traced to abnormal post-injury neuronal activity […]
FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.
Developing freeze-drying processes requires patience and deep product and process understanding.
The guidance is intended to help applicants and manufacturers provide the agency with timely and informative notifications about changes in the production of certain drugs […]
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and […]
Researchers have evaluated microbial contamination surface sampling methods to assess the recovery efficacy of naturally occurring microbe-carrying particles (MCPs). Sterile tryptone soya agar 55mm diameter […]
Bob Hughes (Sr. Principal Scientist, Grace) and Brian Graves (Global Business Manager, Fine Chemicals, Grace) explain how Grace’s experience as a CDMO can help customers […]
Endeavor BioMedicines has completed a third-round financing, raising an impressive $132.5 million to fund trials of its two clinical-stage drug candidates for pulmonary fibrosis and […]
Senator Bernie Sanders is pressing the drugmaker Novo Nordisk for details on its pricing of the popular diabetes and weight loss medications.
From Monday 29 April 2024, the NIPVIP Program will be expanded to allow pharmacies to claim a payment for the off-site administration of National Immunisation […]
A new computer process makes it possible to generate active pharmaceutical ingredients quickly and easily based on a protein’s three-dimensional surface. The new process could […]
Researchers have published results of a phase I clinical trial of a novel immunotherapy for high-risk sarcomas.
Researchers have published results of a phase I clinical trial of a novel immunotherapy for high-risk sarcomas.
If a patient is successfully resuscitated after a cardiac arrest and circulation resumes, they are not out of the woods yet. A number of factors […]
Biogen has given an update on the rollout of its Eisai-partnered Alzheimer’s disease therapy Leqembi alongside its first-quarter results, showing that while the drug’s take-up […]
Shots: An American investment firm, OrbiMed Advisor is a prominent name when it comes to healthcare investments. The company boasts a robust portfolio of 180 […]
in clinical trials [the combination treatment was shown] to halt tumour growth for low-grade gliomas for an average of more than two years” The National […]
PCD Pharma Franchise Price List – Pharmafranchiseeindia.com is the top B2B pharma platform connecting pharmaceutical companies and associates interested in starting their own PCD pharma […]
Roche chief executive Thomas Schinecker said today that one in five of the pharma division’s pipeline of new molecular entities (NMEs) has been culled in […]
Shots: FILSPARI received conditional marketing authorization (CMA) from European Commission for treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (Urine […]
New trial data for a gene therapy presented at the International Myology 2024 Congress has revealed “good” tolerability in Duchenne muscular dystrophy, when combined with […]
After a successful mid-stage study, the companies aim to upend traditional wet AMD treatments with a one-time gene therapy.
In a new agreement, Cellares will utilize its Cell Shuttle fully automated cell therapy manufacturing platform to manufacture select CAR-T cell therapies under development by […]
[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31221-31223] Voluntary Protection Programs; Extension of the Office of Management and Budget’s (OMB) Approval of […]
[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31223-31224] TUV Rheinland of North America, Inc.: Grant of Expansion of Recognition
[Federal Register Volume 89, (Wednesday, April 24, 2024)] [Notice] [Pages 31220-31221] Intertek Testing Services NA, Inc.: Grant of Expansion of Recognition
Shots: Angle and AstraZeneca entered into a supply agreement to develop and validate a methodology using ANGLE’s existing Parsortix-based DNA damage response (DDR) assay to […]
Shots: Neurocrine reports results from SAVITRI, a P-II study (n=183), evaluating safety and efficacy of NBI-1065845 (AMPA) in adults with MDD who had improper response […]
Any new company wanting to make waves in applying artificial intelligence to drug discovery will need deep pockets and a top-tier science and management team […]
The progressive neurodegenerative condition is the most common form of dementia
According to WHO, CVDs are responsible for an estimated 17.9 million deaths every year
An oral therapy that can allow children and adolescents with an aggressive form of brain cancer to be treated at home rather than in hospital […]
Today (April 24), Astellas Pharma Inc. revealed that XTANDITM (enzalutamide) has received a label extension from the European Commission, marking it as the inaugural and […]
India’s pharmaceutical exports surge 9.67% to USD 27.9 billion in 2023-24, despite a 3% dip in total exports. March sees a 12.73% rise to USD […]
India’s pharmaceutical exports surge 9.67% to USD 27.9 billion in 2023-24, despite a 3% dip in total exports. March sees a 12.73% rise to USD […]
Shots: Astellas received label extension approval of Xtandi as monothx or in combo with ADT to treat unsuitable salvage-radiotherapy, adult men with high-risk BCR nmHSPC […]
Orchid Pharma, backed by Dhanuka Group, focuses on cephalosporin antibiotics. Expansion plans include a new facility, Enmetazobactam launch, and mergers for sustainable growth and reduced […]
Orchid Pharma, backed by Dhanuka Group, focuses on cephalosporin antibiotics. Expansion plans include a new facility, Enmetazobactam launch, and mergers for sustainable growth and reduced […]
A new programme announced by the FDA will work towards the use of augmented reality and virtual reality (AR/VR) to make patients’ own homes an […]
Shots: Incyte to acquire Escient Pharmaceuticals for $750 M plus Escient’s remaining net cash at closing of transaction (based on customary adjustments). Closing of acquisition […]
BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of […]
BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of […]
Shots: US FDA granted Fast Track designation to Medicure’s MC-1 for seizures associated with PNPO deficiency. Also received Rare Pediatric Disease Designation and ODD by […]
Algunas versiones pueden provocar dependencia. Esto es lo que sabemos sobre los riesgos.
Sanofi has chalked up another win in a clinical trial of its oral BTK inhibitor rilzabrutinib, setting up regulatory filings in its first indication – […]
[![topiramate structure](https://www.DrugPatentWatch.com/img/drug-structure/topiramate.png)](//www.DrugPatentWatch.com/p/preview/generic-api/topiramate?utm_medium=dpw_wp_blog&utm_campaign=dpw_wp_blog&utm_source=dpw_wp_blog) Topiramate is the generic ingredient in six branded drugs marketed by Upsher Smith Labs, Actavis Labs Fl, Ajanta Pharma Ltd, Alkem Labs Ltd, […]
Annual Drug Patent Expirations for ADZENYS+XR-ODT Adzenys Xr-odt is a drug marketed by Neos Theraps and is included in one NDA. It is available from […]
This chart shows the pharmaceutical companies with the most lotion dosed drugs. For a different perspective, see the most popular dosage types. The companies with […]
By Joshua Rich — The Federal Trade Commission, voting 3-2 along party lines, adopted a Final Rule banning non-compete agreements. The Final Rule allows some […]
HIPAA-covered entities will be barred from disclosing patient records on abortion, IVF or other reproductive healthcare that could be used in an investigation.
Regulations for mRNA products are evolving as the market for mRNA expands.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age […]
2023 Warning Letters – Health Fraud
Researchers describe the steps they took to manipulate DNA and proteins — essential building blocks of life — to create cells that look and act […]
2022 Warning Letters – Health Fraud
Dr Reddy’s Laboratories on Tuesday said it is voluntarily recalling from the US market six lots of medication, indicated to reduce blood phenylalanine (Phe) levels, […]
Dr Reddy’s Laboratories on Tuesday said it is voluntarily recalling from the US market six lots of medication, indicated to reduce blood phenylalanine (Phe) levels, […]
Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products […]
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