Pharma: Page 41
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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 -
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 -
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 -
Dr_Microbe via 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 -
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 -
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 -
Courtesy of Eli Lilly
Lilly ups revenue forecast amid windfall from COVID-19 drugs
While the boost from its COVID-19 treatments might be temporary, Lilly believes next year's revenue will hold up thanks to newer products. Also on the horizon are potential approvals for key Alzheimer's and diabetes medicines.
By Jacob Bell • Dec. 15, 2021 -
Permission granted by Bristol-Myers Squibb
Bristol Myers returns to Immatics for a dual-targeting cancer drug
The pharma has expanded an alliance with a German biotech by paying $150 million for a drug candidate that executives hope can have "cell therapy-like efficacy" for solid tumors.
By Ben Fidler • Dec. 14, 2021 -
Permission granted by Roche
Latest Roche results show promise for new type of cancer immunotherapy
Updated Phase 2 data suggested an experimental drug targeting the protein TIGIT could bolster the benefit of Roche's Tecentriq in certain people with advanced lung cancer.
By Ben Fidler • Dec. 10, 2021 -
Courtesy of AstraZeneca
AstraZeneca antibody cleared by FDA for preventive use against COVID-19
Evusheld, a combination of two antibodies, is meant to be long-acting, proving protective against disease through six months in clinical testing.
By Ned Pagliarulo • Dec. 8, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine from Medicago, GSK protective against COVID-19 in large study
The vaccine, which Medicago plans to soon submit to Canadian regulators, would be the first of its type, though supply appears likely to be limited.
By Jonathan Gardner • Dec. 7, 2021 -
Courtesy of Eli Lilly
Lilly drug becomes first COVID antibody cleared for use in young children
The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.
By Jonathan Gardner • Dec. 6, 2021 -
Permission granted by Novartis
Novartis pays $150M for access to UCB's Parkinson's drug
UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.
By Jonathan Gardner • Dec. 2, 2021 -
Courtesy of Merck & Co.
FDA panel, after debate, narrowly backs Merck COVID pill
While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease.
By Jonathan Gardner • Updated Nov. 30, 2021 -
Warren Little via Getty Images
GSK hires away top Pfizer vaccine scientist
Philip Dormitzer, who helped Pfizer develop shots for COVID-19, RSV and influenza, will become the British pharma's head of vaccine R&D next month.
By Ned Pagliarulo • Nov. 30, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Vaccine makers move quickly to confront omicron threat
Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.
By Ned Pagliarulo • Nov. 29, 2021 -
Courtesy of Merck & Co.
New Merck study results raise questions about its COVID pill
Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.
By Ben Fidler • Nov. 26, 2021 -
Dr_microbe via Getty Images
Takeda wins US approval for new CMV treatment
The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.
By Kristin Jensen • Nov. 24, 2021
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