The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Eli Lilly and Company reports that a federal district court has ruled in its favor in patent litigation over Alimta (pemetrexed for injection), used to treat certain types of lung cancer. The drug is one of the company’s top-selling products with...
ViiV Healthcare, a specialist HIV company majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application...
Astellas Pharma has acquired Xyphos Biosciences, a South San Francisco, California-based company specializing in immuno-oncology products, for $120 million upfront and future development milestones for a total transaction value of $665...
In another industry recall of ranitidine products, Glenmark Pharmaceutical Inc. USA announced on December 17, 2019, a voluntary recall of all unexpired lots of ranitidine tablets, 150 mg and 300 mg, to the consumer level because of the...
UCB has announced that it will build a multi-product biological manufacturing facility on its site in Braine l’Alleud, Wallonia, Belgium. The new biotechnology plant is being constructed to accompany the company’s growth and prepare for the launch...
Roche has signed a licensing agreement, worth up to $2.85 billion ($1.15 billion upfront), with Sarepta Therapeutics, a Cambridge, Massachusetts-based biopharmaceutical company, to provide Roche with exclusive commercial rights outside the US to...
Sumitomo Dainippon Pharma and Roivant Sciences, a technology-enabled healthcare company, have completed a deal to form their previously announced strategic alliance and have formed a new company, Sumitovant Biopharma, in a $3-billion deal. Sumitomo...
Amgen has acquired an equity stake in BeiGene, a Beijing-based pharma company, for $2.8 billion and formed a strategic oncology-drug pact with BeiGene in China and globally. The companies had announced the deal last year (November 2019).
BeiGene...
AbbVie has extended its exchange offer expiration date in its pending $63-billion acquisition of Allergan until January 31, 2020. The exchange offer period was scheduled to expire on December 31, 2019. AbbVie announced the acquisition last year...
The US Senate has confirmed Dr. Stephen Hahn of MD Anderson Cancer Center to serve as the next Commissioner of the US Food and Drug Administration. The Senate confirmed Dr. Hahn on December 12, 2019 with a vote of 72 in favor to 17 against.
Dr....
Pfizer announced that Ian Read, currently Pfizer’s Executive Chairman, will join the board of Viatris, the planned combination of Mylan, a generic-drug company, and Upjohn, Pfizer’s off-patent branded and generics medicines business, upon...
As part of a plan to lower the cost of prescription drugs, President Donald Trump, along with the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA), have issued a notice of proposed rulemaking (NPRM)...
A roundup of developments and latest news from Germany (AstraZeneca, Cheplapharm), India (Sun Pharmaceuticals), United States (Amneal, Eli Lilly and Company, Sanofi).
Germany
AstraZeneca Completes Agreement with Cheplapharm for...
The US House of Representatives has passed a proposed drug-pricing plan (H.R.3, Elijah E. Cummings Lower Drug Costs Now Act).
The bill, which was first introduced in the House in September 2019, would establish a fair price negotiation program,...
Bausch Health (formerly Valent Pharmaceuticals) has reached a $1.21-billion settlement in putative securities class action litigation initially brought against Valeant in a federal district court in New Jersey in October 2015. Valeant took the name...
