Analysis: Necessary or Not, Covid Booster Shots Are Probably on the Horizon
The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and […]
The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and […]
The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic […]
In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA’s approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone […]
Shots: The approval is based on KD025-213 study evaluating Rezurock (200 mg, qd) aged >12 yrs. in 65 patients with cGVHD who had received 2 […]
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 […]
The FDA has approved a new pneumococcal vaccine from Merck & Co, just over a month after Pfizer got a green light for a new […]
Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 […]
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 […]
Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) […]
Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you […]
Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that […]
At 15, Autumn Fuernisen is dying. She was diagnosed at age 11 with a rare degenerative brain disorder that has no known cure or way […]
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: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with […]
Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA […]
The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also […]
In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen […]
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, […]
AliveCor’s at-home EKG device won FDA clearance to calculate a heart’s QT interval, a measurement of how long it takes the ventricles to contract and […]
AliveCor’s at-home EKG device won FDA clearance to calculate a heart’s QT interval, a measurement of how long it takes the ventricles to contract and […]
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 […]
One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use […]
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 […]
Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) […]
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter […]
The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, […]
Shots: The P-II trial will assess the efficacy & safety of RTX across several dose groups vs PBO in patients with a mod. to sev. […]
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: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients […]
Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last […]
If you could invest $56 billion each year in improving health care for older adults, how would you spend it? On a hugely expensive medication […]
Neuralace Medical, a San Diego-based startup, recently got FDA clearance for a non-invasive device to treat chronic pain. It works by stimulating nerve fibers that […]
Shots: The NDA is based on two P-III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China. The anticipated PDUFA date is […]
Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy […]
Shots: The US FDA has approved FoundationOne CDx to be used as a CDx for Alunbrig (brigatinib) which is approved for the treatment of adult […]
Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you […]
Shots: The approval is based on clinical data from an ongoing P-II/III JZP458-201 trial evaluating Rylaze in pediatric and adult patients aged ≥1mos. with ALL […]
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 […]
Quanta, a company making portable dialysis systems, raised $245 million in a series D funding round. The company plans to study its device for in-home […]
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, […]
KHN correspondent Rachana Pradhan discussed the politics of unused Johnson & Johnson covid vaccines and the FDA’s potential announcement that their shelf life can be […]
Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you […]
Shots: The full FDA approval is based on data from 2 clinical trials i.e., P-I EXPLORER & P-II PATHFINDER trial evaluating the efficacy of Ayvakit […]
Lucien Wiggins, 12, arrived at Tufts Children’s Hospital by ambulance June 7 with chest pains, dizziness and high levels of a protein in his blood […]
Shots: The NDA is based on data from the BREEZE study evaluating Tyvaso DPI in 51 patients with PAH transitioning from Tyvaso inhalation solution which […]
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 […]
With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy […]
Shots: Jounce to receive $85M upfront and $35M in its common stock under the terms of Sep 2020 agreement. Additionally, it is eligible to receive […]
The startup will work with the FDA to evaluate the efficacy and safety of current cancer treatments in different groups of cancer patients.
Shots: The US FDA has approved the IND application of oral Asieris’ APL-1202 + BeiGene’s tislelizumab as neoadjuvant therapy in patients with MIBC The P-I/II […]
The top-line phase 3 data for Novavax’ COVID-19 vaccine look good, with a 90% overall efficacy rate, but a dip in its share price indicates […]
The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be […]
KHN chief Washington correspondent Julie Rovner discussed the FDA’s approval of a new drug for Alzheimer’s disease on WAMU’s “1A” on Wednesday. Click here to […]
The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning […]
Ocugen is the first company to be affected by the FDA’s recent decision to raise the bar on emergency use authorisations for COVID-19 medicines, and […]
Shots: The US FDA has approved the NDA of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 […]
Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you […]
Shots: The approval is based on a P-III study evaluating the safety, PK & efficacy of Trikafta in 66 children aged 6-11yrs. old with CF […]
Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote […]
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 […]
The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the […]
Pfizer has the FDA approval it was seeking for Prevnar 20, the latest update to its blockbuster pneumococcal vaccination franchise, keeping it one step ahead […]
Shots: The approval is based in the clinical program including P-I & II trials, and three P-III trials evaluating the safety & immunogenicity of Prevnar […]
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 […]
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. […]
Shots: The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of […]
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 […]
Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s […]
Shots: The approval is based on the results from the P-IIIa STEP clinical trial program evaluating Wegovy (2.4mg injection, qw) in ~4,500 adults with obesity […]
The system, developed by digital health startup Cognoa, uses information from questionnaires and videos to help pediatricians diagnose autism. It received marketing authorization from the […]
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 […]
Shots: The submission is based on data from the P-III PSOARING 1 & PSOARING as well as interim results from PSOARING 3 long-term safety study […]
The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits […]
The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after […]
What You Should Know: – Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, has been […]
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 […]
Shots: The FDA’s BT and EMA’s PRIME designations are based on data from the P-I MajesTEC-1 study evaluating the safety and efficacy of teclistamab (Ab […]
Shots: The approval is based on two P-III studies evaluating Cosentyx (75 mg/ 150 mg) vs PBO in children aged 6 to <18 yrs with […]
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 […]
An action plan shared by the FDA earlier this year showed how the regulator is thinking about future regulations for AI and machine learning in […]
After decades of mostly unsuccessful R&D, Amgen has claimed the first ever regulatory approval for a drug that inhibits KRAS – a cancer target that […]
Shots: The NDA submission is based on data from the ongoing P-III MOVE trial evaluating the efficacy and safety of palovarotene (chronic/flare-up dosing regimen) in […]
Shots: The company has announced the resubmission of a label expansion application to the US FDA for the existing marketing authorization for Ozempic to introduce […]
Shots: The approval is based on a P-II study assessing Truseltiq (125mg, qd, for 21 days of 28-day cycles) in 108 patients who had undergone […]
Shots: The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg, qd) in 124 patients with KRAS G12C […]
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 […]
Shots: EMDAC has voted 10-7, confirming that the benefits of teplizumab outweigh the risks supporting the approval to delay T1D Mellitus The recommendation is based […]
Shots: The approval is based on a P-III True North trial assess Zeposia (0.92 mg) vs PBO in an adult with mod. to sev. active […]
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 […]
It’s important for clinicians to consider AI recommendations with a critical eye, the same as they would for any other test, said Dr. Erich Huang, […]
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 […]
GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA […]
Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 […]
Shots: The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression 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 […]
Shots: The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 […]
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 […]
Shots: The BTD is based on P-II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia Moreover, the company […]
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. […]
Shots: The US FDA has granted accelerated approval which is based on P-I CHRYSALIS study assessing Rybrevant as a monothx. in patients metastatic non-small cell […]
Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal […]
FDA draft guidance published this month says you should. In most cases, adjusting for covariates is not necessary. Randomization generally insurers that covariates are balanced […]
High doses of lycopene—the red pigment in tomatoes—were put to the test to see if it could prevent precancerous prostate lesions from turning into full-blown […]
Shots: The NDA submission is based on P-III studies (SERENITY I & II) assessing BXCL501 (120 & 180mcg doses) vs PBO for the acute treatment […]
In a rare move, the FDA has publicly accused US biotech CytoDyn of misrepresenting clinical trial results for leronlimab, an antibody being developed for COVID-19. […]
Shots: The companies enter into a license agreement for the Preserflo MicroShunt superseding the previous collaboration between the two parties Glaukos get exclusive commercialization rights […]
Shots: Agenus to receive a $200M as up front & ~$1.36B as development, regulatory and commercial milestones plus royalties on net sales of the therapies. […]
Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, […]
Shots: The P-II study involves assessing the safety & immunogenicity of the CoVLP vs PBO in 306 subjects aged ≥18yrs. with two age groups (18-64yrs […]
Shots: Roche’s cobas SARS-CoV-2 test to be use on high-throughput cobas 6800/8800 systems has received the US FDA’s EUA for testing individuals without symptoms or […]
Shots: The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L […]
CMS delayed the start date of its rule that would provide expedited Medicare coverage for products the FDA deems “breakthrough devices” from May 15 to […]
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 […]
Shots: The approval is based on P-III head-to-head PEGASUS study assessing Empavel vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable […]
Nastassia Tamari, Director of Information Security Operations for BD According to the National Vulnerability Database, 18,353 vulnerabilities were reported in 2020. That’s nearly three times […]
Shots: The US FDA approved Zynrelef (bupivacaine and meloxicam) extended-release solution for postsurgical analgesia in patients with soft tissue or periarticular instillation for 72 hrs […]
Can’t see the audio player? Click here to listen on SoundCloud. The high cost of prescription drugs is a top health issue for the public and […]
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 […]
The startup received 510(k) clearance for its “smart” insulin pen cap, which pulls in data from users’ connected glucose monitor to help them calculate the […]
What You Should Know: – Today, Johnson & Johnson Vision announced that the U.S. Food and Drug Administration (FDA) has approved ACUVUE® Abiliti™ Overnight Therapeutic Lenses, the first and only orthokeratology […]
Shots: The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients […]
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The […]
The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s […]
Shots: The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults […]
Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants […]
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 […]
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 […]
Can’t see the audio player? Click here to listen on SoundCloud. The Biden administration — keeping a campaign promise — announced it would back a temporary […]
Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a […]
A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for […]
The FDA has extended a collaboration with the UK firm CN Bio to investigate a “lung-on-a-chip” model to investigate inhaled drugs. In a statement the […]
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 […]
AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA […]
The quick detection of an ultra-rare blood clotting reaction in some covid-19 vaccine recipients showed the power of a federal warning system for vaccine safety […]
Shots: The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 […]
Shots: The filing is based on results from the P-III CheckMate -274 trial evaluating Opdivo (240mg, q2w for up to 1 yrs.) vs PBO in […]
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) […]
June 22 – 23, 2021 (EDT) | Virtual Conference The American Conference Institute invites you to attend the Virtual 12th Summit on Biosimilars & Innovator Biologics on […]
Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of […]
Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, […]
Dosing can start once again in uniQure’s phase 3 trial of its haemophilia B gene therapy, after the FDA concluded that a case of liver […]
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. […]
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 […]
The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer. With […]
Shots: The US FDA has approved the BLA filing for Jemperli for adult patients with dMMR recurrent or advanced solid tumors endometrial cancer, as determined […]
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 […]
Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of […]
Shots: The US FDA has approved Pipeline Flex Embolization Device with a Shield Technology to advance flow diversion therapy that demonstrates a reduction in material […]
In the final days of the Trump Administration, the Department of Health and Human Services sought to deregulate 83 different types of medical devices, citing […]
Shots: The US FDA has granted FT Designation to LX1001 for the treatment of APOE4 associated AD. The designation evaluates to facilitate the development and […]
The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has […]
Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated […]
Can’t see the audio player? Click here to listen on SoundCloud. The effort to vaccinate Americans against covid-19 took a hit this week. The Centers for […]
Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine. Doctors have used the drug […]
Amylyx’s ALS drug met the goals of a mid-stage study, paving the way for regulatory submissions in Europe and Canada. But the FDA is requiring […]
A phase 3 trial of Romark’s antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, […]
Federal officials announced new measures to help get fresh, new N95 masks to health care workers and expand their use in other industries after scientists […]
Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, […]
In a review of 130 FDA-cleared AI tools, researchers found that the vast majority of them relied on retrospective studies. Most of the developers also […]
Blood clots found in six people given Johnson & Johnson’s Covid-19 vaccine have led federal health officials to recommend a pause on dosing with that […]
US health authorities have recommended pausing dosing with Johnson & Johnson’s COVID-19 vaccine as they investigate cases of blood clots also observed in some people […]
Shots: The US FDA has approved the sBLA for a new self-administration option for Xolair in patients across all approved indications in the US The […]
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug […]
The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) […]
Shots: Lilly and Incyte reported that the US FDA has extended the review period of sNDA for baricitinib to treat adults with mod. to sev. […]
The agency said it had received more than 450 reports of infections or other issues in the last four years from reprocessed urological endoscopes, which […]
UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates […]
Shots: The US FDA has accepted IND to assess the safety, tolerability, PK, and preliminary antitumor activity of XB002 in patients with advanced solid tumors. […]
Acadia Pharmaceuticals is butting heads with US regulators again, this time over the FDA’s decision to reject its Nuplazid (pimavanserin) for use in dementia-related psychosis […]
FDA approval of Supernus Pharmaceuticals drug Qelbree gives attention-deficit hyperactivity disorder patients another treatment option that is not classified as a Schedule II substance. It’s […]
The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company […]
Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The […]
A Helius Medical Technologies medical device that stimulates the brain by sending electrical stimulation to the tongue has received FDA clearance for multiple sclerosis patients. […]
The Food and Drug Administration gave an emergency use authorization to two more over-the-counter Covid-19 tests that can be used without a prescription. They include […]
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The […]
Shots: The sBLA is based on data from the P- I/II ZUMA-3 trial in adult patients age ≥18 years old for the treatment of adult […]
Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The […]
The FDA decision for Tyvaso as a treatment for pulmonary arterial hypertension in patients who have interstitial lung disease is the second approval for the […]
Shots: The approval is based on P-III IKEMA study involves assessing of Sarclisa + carfilzomib and dexamethasone(kd) vs SOC in 302 patients with RRMM who […]
¿Podría un antidepresivo que se usa desde hace décadas ser un arma secreta contra covid? Algunos científicos creen que sí, después de que dos pequeños […]
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The […]
Shots: The US FDA has granted EUA for Qiagen’s NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay that will help in identifying and differentiate individuals suspected of respiratory […]
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 […]
Could a decades-old antidepressant be a secret weapon against covid? A few scientists think so, after two small studies showed that fluvoxamine, typically prescribed for […]
This story also ran on Los Angeles Times. It can be republished for free. Here’s one big takeaway from our country’s disastrous 2020 covid response: […]
Shots: The approval is based on two clinical studies and a retrospective analysis of RWD. The device is intended to be used by prescription only […]
One of the frustrations of our Big Data era is that, despite the existence of an ever-growing wealth of valuable data, this data is often […]
Shots: The approval is based on the P-II KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy […]
Earlier this year, AppliedVR shared results of a pivotal study that it plans to submit to the FDA. It received a breakthrough device designation last […]
Dr. Miller, Medical Director of CancerLinQ LLC Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — […]
Can’t see the audio player? Click here to listen on SoundCloud. As questions swirl about the covid vaccine made by AstraZeneca, public health experts are worried […]
The former top White House coronavirus adviser under President Donald Trump, Dr. Deborah Birx, has joined an air-cleaning company that built its business, in part, […]
Shots: The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D […]
What You Should Know: – AppliedVR, a Los Angeles, CA-based company advancing the next generation of digital medicine, today announced $29 million in Series A […]
Six months after it was controversially hailed by Trump administration officials as a “breakthrough” therapy to fight the worst effects of covid-19, convalescent plasma appears […]
Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children […]
Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
Lisa Romano, MSN, RN, Chief Nursing Officer at CipherHealth The New Year brings hope and promises that an end to the COVID-19 pandemic is in […]
Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at […]
Melinta Therapeutics already sells an antibiotic for serious skin infections. But FDA approval of Kimyrsa gives clinicians another option to offer patients, one with more […]
Shots: The BTD is based on a P-Ib/II TRANQUILITY study assessing BXCL501 in patients with acute treatment of agitation associated with dementia, including AD The […]
President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But right now, the gap between supply and demand […]
In two pivotal studies years apart, Aveo Oncology’s drug tivozanib did not help kidney cancer patients live longer overall compared to the standard of care. […]
The positive data for the antibody drug from Vir Biotechnology and GlaxoSmithKline give a clearer picture of how and when these treatments could help. Last […]
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The […]
Shots: The US FDA has granted FTD for VX-880 to treat T1D. The designation is designed to facilitate the development and expedite the review of […]
Shots: The US FDA provide feedback on the pivotal trial protocol and statistical analysis plan (SAP) for the development program of biosimilar insulin glargine candidate, […]
Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked […]
Eli Lilly reported data from a second group in a Phase 3 study testing its combination antibody drug for Covid-19 showing that the treatment reduced […]
Bluebird bio said independent analyses found that the gene therapy inserted its payload at a site not known to cause cancer. Based on the results, […]
Pfizer’s management knew last year there was “a mold issue” at the Kansas facility now slated to produce the drugmaker’s urgently needed covid-19 vaccine, according […]
Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s […]
Each night it’s the same. Story after story on the TV news is about the covid vaccination effort, and they are all illustrated with footage […]
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on […]
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third […]
Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with […]
Satsuma Pharmaceuticals executives say they now understand why their intranasal migraine treatment failed a pivotal test. But even with a new Phase 3 plan, the […]
As the Biden Administration pushes to offer more over-the-counter Covid-19 tests, the Food and Drug Administration authorized the first molecular Covid-19 test for over-the counter […]
What You Should Know: –BioIntelliSense announced it has entered into a strategic partnership with The Leukemia & Lymphoma Society (LLS) to incorporate the BioSticker™ platform […]
Jon Gingrich, CEO, Echosens North America Leveraging technological advances to facilitate new ways of engaging patients and integrating non-invasive technology into a liver disease program […]
Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The […]
Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation […]
Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated […]
A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA […]
Joan Kapusnik-Uner PharmD, FCSHP, FASHP, VP of Clinical Content for First Databank (FDB) As the Biden administration ramps up its efforts to increase the access of […]
Shots: On Feb 12, 2021, the US FDA has approved Cosela to decrease the incidence of CT induced myelosuppression in adult patients when administered before […]
Shots: The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio […]
Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs […]
Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC […]
Athenex’s bid to offer an oral version of an intravenous chemotherapy has stalled after the FDA rejected the drug. Among the remedies proposed by the […]
The FDA decision makes Nulibry the first drug approved to treat MoCD type A, a rare metabolic disease. It’s also the first FDA-approved product for […]
Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA […]
The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded […]
Shots: The FDA has approved Nulibry based on three clinical trials compared to data from a natural history study in patients with MoCD Type A […]
Johnson & Johsnon’s Covid-19 vaccine is now the third one granted FDA emergency authorization. The company expects to deliver enough vials to for vaccinating more […]
The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh its risks. FDA emergency use authorization would […]
This story also ran on Fortune. It can be republished for free. The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine […]
The FDA decision gives Sarepta Therapeutics its third approved drug for Duchenne muscular dystrophy. The accelerated approval requires the biotech to conduct additional clinical testing […]
Diversity in clinical trials Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the […]
Shots: The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to […]
This story also ran on NBC News. It can be republished for free. Covid-19 infections from variant strains are quickly spreading across the U.S., but […]
Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the […]
Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in […]
Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) […]
Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. The approval in first-line […]
Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory […]
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