Pharma

Pfizer pledges not-for-profit sale of medicines in low-income countries

The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.

By Jonathan Gardner • May 25, 2022

Pfizer, Lilly bolster cases for experimental ulcerative colitis drugs

The two companies are each developing new types of medicines that they hope can soon win FDA approval for treating the autoimmune disease.

By Ned Pagliarulo • May 24, 2022

Explore the Trendline➔

The expanding world of RNA therapies

Vaccines from BioNTech and Moderna proved the power of messenger RNA in medicine. A growing field of RNA-targeting therapies is advancing alongside them.

By BioPharma Dive staff

Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

By Jonathan Gardner • May 23, 2022

Common barriers to patient engagement: What's your strategy?

As with treatment, and even adherence, there is no 'one size fits all' when it comes to patient engagement.

May 23, 2022

Bayer backs out of Atara cell therapy deal

The German drugmaker will hand back rights to two CAR-T cell therapies it was developing with Atara, which said it would reassess its strategy for the programs.

By Ned Pagliarulo • May 20, 2022

AbbVie asks FDA to approve Parkinson's treatment

The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie.

By Jacob Bell • May 20, 2022

Bristol Myers' Opdivo comes up short in bladder cancer trial

The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.

By Ned Pagliarulo • May 16, 2022

Making sub-visible particles visible

Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination. 

By Dr. Melanie Zerulla-Wernitz, Head of the Analytical Science Laboratory, Vetter Pharma • May 16, 2022

Lilly wins FDA approval for new kind of diabetes drug

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

By Jonathan Gardner • Updated May 16, 2022

FDA approves oral version of Mitsubishi's ALS drug

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use.

By Jacob Bell • May 13, 2022

Key Bristol Myers drug holds up in long-term psoriasis study

Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.

By Jonathan Gardner • May 12, 2022

Bristol Myers acquires BridgeBio drug aimed at emerging cancer target

The pharma will pay $90 million to license BridgeBio's experimental candidate, joining a lengthening list of large drugmakers aiming to treat cancer by blocking a protein called SHP2.

By Ned Pagliarulo • May 12, 2022

Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.

By Ben Fidler • May 11, 2022

Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

The deal, which hands Pfizer full rights to the biotech's fast-selling Nurtec ODT, could provide a much needed spark for the sector after months of stock market declines. 

By Ben Fidler , Jacob Bell • Updated May 10, 2022

J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

By Ned Pagliarulo • May 9, 2022

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.  

By Ned Pagliarulo • May 6, 2022

Digital key opinion leaders: who are they?

As scientific discussions increase online, Medical Affairs teams need ways to listen to conversations.  

May 2, 2022

Bristol Myers wins FDA approval for first drug to treat inherited heart condition

Bristol Myers paid $13 billion to acquire the drug's maker, MyoKardia, and expects it to become a blockbuster. But a tricky dosing regimen, as well as safety concerns, could challenge the pharmaceutical giant's lofty forecast. 

By Jonathan Gardner • April 28, 2022

Lilly's closely watched diabetes drug scores in obesity trial

Called tirzepatide, the drug significantly lowered weight loss in a large study, findings that add to growing evidence that a class of medicines originally meant for diabetes may effectively treat obesity.

By Jonathan Gardner • April 28, 2022

FDA sets back Novartis' best chance at a COVID-19 drug

The agency indicated another trial of the drug, developed by Molecular Partners, will be needed. But whether such a study is doable is yet to be determined, according to Novartis' CEO Vas Narasimhan.

By Kristin Jensen • April 27, 2022

Novartis names longtime analyst as top dealmaker amid organizational shakeup

Novartis said in an earnings presentation Tuesday that it hired biotech analyst Ronny Gal as chief strategy and growth officer and revealed more details about planned layoffs as the company restructures.

By Ben Fidler • April 26, 2022

Nektar begins sweeping layoffs after $2B Bristol Myers deal falls apart

Loss of the lucrative partnership has triggered a wide-ranging restructuring that will pare down Nektar’s workforce by about 70%.

By Jonathan Gardner • April 26, 2022

Roche stumbles in latest setback for an emerging group of breast cancer drugs

The Phase 2 failure marks the second negative result in two months for a closely watched group of medicines, known as SERDs, that are being developed by several large pharmaceutical companies.

By Jonathan Gardner • April 25, 2022

Connect to the conversation: Pediatric mental health

More children than ever are experiencing mental health issues, so what can parents and loved ones do to help address these issues and prevent them before they start?

April 25, 2022

Drug price hikes moderate as rebates rise, report finds

List prices for branded medicines rose by nearly 5% last year, according to IQVIA, a figure that fell to 1% after accounting for rebates and discounts.

By Ned Pagliarulo • April 21, 2022