Pharma: Page 49
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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 -
Explore the Trendline➔
Brian Tucker / BioPharma Dive/BioPharma Dive
TrendlineTop 5 stories from BioPharma Dive
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 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 -
Mario Tama via Getty Images
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 questions facing the FDA in 2022
If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.
By Jonathan Gardner • Jan. 11, 2022 -
Danielle Ternes/BioPharma Dive
JPM22: Pfizer's big bet on mRNA, Biogen 'proven wrong' on Aduhelm price and the next cell therapies
The healthcare conference's first day brought a trio of mRNA deals from Pfizer, a rare admission from Biogen's CEO and new focus on what's next in cell therapy.
By Ned Pagliarulo , Jonathan Gardner , Jacob Bell • Jan. 10, 2022 -
Permission granted by UPS Healthcare
Sponsored by UPS HealthcareThe pandemic isn't over; neither is the new era of healthcare logistics
We have to focus on maintaining a sustainable, collaborative supply chain that delivers for everyone on this hard road ahead.
Jan. 10, 2022 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
US pauses distribution of Regeneron, Lilly antibodies over omicron concerns
The decision follows worrisome results in lab studies that indicated omicron can evade both drugs and leaves the U.S. with fewer treatments to respond to the variant's spread.
By Ben Fidler • Updated Jan. 4, 2022 -
Permission granted by Novartis
Novartis wins FDA approval for new heart drug, but faces uphill sales battle
Leqvio, which Novartis acquired for nearly $10 billion two years ago, arrives with high sales expectations. But uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness.
By Jonathan Gardner • Dec. 22, 2021 -
Dan Kitwood via Getty Images
COVID-19 pills from Pfizer, Merck authorized by FDA in major pandemic milestone
Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S.
By Jonathan Gardner • Updated Dec. 23, 2021 -
Novartis ups investment in gene therapy for the eye with $800M buyout
The deal for Gyroscope Therapeutics, worth up to $1.5 billion, gives the Swiss pharma access to a treatment for a type of age-related blindness as well as new means of delivering drugs into the eye.
By Jonathan Gardner • Dec. 22, 2021 -
GSK's long-acting HIV shot approved for preventive use
The landmark FDA approval makes Apretude the first injectable treatment in the U.S. for HIV pre-exposure prophylaxis.
By Jacob Bell • Dec. 21, 2021 -
Getty Images
Duchenne patient dies in Pfizer gene therapy study
The tragic news follows changes Pfizer recently made to the design of another study testing the therapy due to side effects seen in some participants.
By Jonathan Gardner • Dec. 21, 2021 -
Courtesy of Sanofi
Sanofi to buy cancer immunotherapy biotech for $1B
The French drugmaker is interested in Amunix Pharmaceuticals' technology, which could allow for more precise delivery of biologic drugs into cancerous tissue.
By Ned Pagliarulo • Dec. 21, 2021 -
Spencer Platt via Getty Images
EU regulator says member countries can use Pfizer's experimental COVID pill
The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.
By Ned Pagliarulo • Dec. 16, 2021 -
Flush with cash, large drugmakers turn to share buybacks, deals
Novartis is using funds gained from the recent sale of its stake in Roche to buy back $15 billion worth of its own shares, while Pfizer is signaling more dealmaking could follow its buyout of Arena.
By Ned Pagliarulo • Dec. 16, 2021 -
Jeenah Moon via Getty Images
Pfizer opens gene therapy plant in $800M North Carolina expansion
The new facility cost nearly $70 million to build, and is part of a major push by the pharma giant to become a leader in genetic medicine manufacturing.
By Kristin Jensen • Dec. 16, 2021
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