Pharma: Page 40
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Sponsored by Aytu BioPharmaPharmaceutical OTC brands are being outcompeted by private-label OTC brands in retail and e-commerce marketplaces
Self-care and the resulting increased use of over-the-counter (OTC) medications is a growing global trend.
Feb. 28, 2022 -
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Lilly, Boehringer diabetes pill wins expanded use in heart failure
The FDA OK greatly broadens the number of patients eligible for Jardiance, which first won approval in 2014 as a treatment for low blood sugar in people with diabetes.
By Jonathan Gardner • Feb. 25, 2022 -
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Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.
By BioPharma Dive staff -
Courtesy of Eli Lilly
Lilly puts $700M into genetic medicine institute
Building on Lilly's acquisition of Prevail Therapeutics, the Boston-based facility will use RNA- and DNA-based technologies to develop new drugs, while also supporting biotech startups in the area.
By Jacob Bell • Feb. 22, 2022 -
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Citing safety signal, GSK pauses some trials of new RSV vaccine
As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.
By Jonathan Gardner • Feb. 18, 2022 -
Jacob Bell/BioPharma Dive
Merck promotes 3 executives to lead human health business
The appointments come after Frank Clyburn left to run IFF and are part of broader executive turnover at Merck.
By Kristin Jensen • Feb. 16, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Lilly's new COVID-19 antibody becomes US' latest tool to battle omicron
The speedy clearance of Lilly’s bebtelovimab comes after the U.S. stopped distributing two of the company's earlier antibodies because they couldn't effectively neutralize the variant.
By Jonathan Gardner • Updated Feb. 11, 2022 -
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Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback
Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.
By Ned Pagliarulo • Feb. 10, 2022 -
Amgen expects rising sales through 2030, but Wall Street still has doubts
Facing falling sales of top-seller Enbrel, the biotech tried to shore up confidence in its ability to grow new products, like the cancer drug Lumakras.
By Kristin Jensen • Feb. 9, 2022 -
Lisa Maree Williams via Getty Images
Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine, pill
The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5%.
By Ned Pagliarulo • Feb. 8, 2022 -
Courtesy of Sanofi
Sanofi's Bioverativ deal begins to pay dividends with first new drug approval
The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.
By Jonathan Gardner • Feb. 7, 2022 -
Courtesy of Eli Lilly
Lilly slows FDA submission of Alzheimer's drug after Medicare decision
Executives for the pharma downplayed the impact of an accelerated approval for donanemab, pointing to Medicare's plans to restrict coverage of Alzheimer's drugs like it to only patients in clinical trials.
By Jonathan Gardner • Feb. 3, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids
The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5 years of age continues.
By Kristin Jensen • Feb. 2, 2022 -
Dan Kitwood via Getty Images
Pfizer lures research chief from Roche, prompting high-level reshuffle
William Pao led discovery and early development at the Swiss drugmaker, and will now head Pfizer's global efforts to launch new products.
By Jonathan Gardner • Feb. 1, 2022 -
Permission granted by Biogen
Biogen buys into fast-advancing Roche cancer drug
The biotech will pay $30 million to opt into rights for mosunetuzumab, a bispecific antibody that Roche has developed for non-Hodgkin's lymphoma.
By Ned Pagliarulo • Feb. 1, 2022 -
Roche wins FDA approval for rival to Regeneron's lucrative eye drug
The drug, which will be sold as Vabysmo, is the first of several emerging competitive threats to Regeneron's top-selling Eylea, along with biosimilars and long-acting implants.
By Jonathan Gardner • Jan. 31, 2022 -
Courtesy of Regeneron Pharmaceuticals
Regeneron, Sanofi are latest to withdraw a cancer drug application
The partners pulled their request after disagreeing with the FDA on post-approval studies for their immunotherapy Libtayo in cervical cancer. Incyte made a similar decision earlier this week.
By Jonathan Gardner • Jan. 28, 2022 -
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J&J 'constantly looking' at biotech M&A, but focused on small, mid-sized deals
Despite sliding stock prices, biotechs aren't "on sale," J&J CFO Joe Wolk said Tuesday. "It's really hard to say whether there's been a capitulation, or a recognition, that values have come down."
By Ned Pagliarulo • Jan. 25, 2022 -
Jacob Bell/BioPharma Dive
Merck drug for chronic cough rejected by FDA
According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.
By Ned Pagliarulo • Jan. 24, 2022 -
Top Merck executive to depart company for CEO role at ingredients maker
Frank Clyburn, a Merck veteran and head of the company's human health division, will leave next month to run IFF, following the exit of other top leaders at the drugmaker.
By Ned Pagliarulo • Jan. 20, 2022 -
Courtesy of GSK
GSK loses R&D chief Barron to high-powered startup amid investor pressure
Hal Barron, a key figure in GSK's efforts to revitalize its drug research, will step down as its top scientist at a time when the company is feeling heat from investors to deliver faster growth.
By Ned Pagliarulo , Jonathan Gardner • Updated Jan. 19, 2022 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
Antitrust regulators aim to revamp merger guidelines, signaling threat to health sector deals
The news sparked headlines about an attempt by regulators to target big tech, but it could have serious implications for healthcare, too.
By Samantha Liss • Jan. 19, 2022 -
FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi
AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.
By Jacob Bell • Jan. 18, 2022 -
Danielle Ternes/BioPharma Dive
JPM22: Aftershocks for Lilly, CRISPR versus CRISPR and Bluebird's crucial year
A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology.
By Ned Pagliarulo , Ben Fidler • Jan. 12, 2022 -
Danielle Ternes/BioPharma Dive
JPM22: M&A anxiety, Roche's comeback plan and Vir's omicron moment
Pharma executives fielded many questions about their dealmaking intentions on the conference's second day, while Roche outlined its plan to compete against Merck and Bristol Myers in cancer immunotherapy.
By Ben Fidler , Ned Pagliarulo • Jan. 11, 2022 -
Permission granted by Biogen
Medicare proposes to limit coverage of Biogen Alzheimer's drug
The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.
By Jonathan Gardner , Jacob Bell • Updated Jan. 11, 2022
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