Gainesville, Fla.-based Applied Genetic Technologies Corporation (AGTC) announced yesterday that its collaboration with Biogen, Inc. has now closed. Originally announced on July 2, 2015, the deal has met all the conditions under the Hart-Scott-Rodino Antritrust Improvements Act of 1976 and is good to go. The deal, announced in July, was a collaboration and licensing […]
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
In seeking innovative players that could change pharma and healthcare, Med Ad News found the developer of an app that helps people determine what illnesses are in their neighborhoods; the creator of a wearable injector that allows patients on biologics to receive these drugs outside the clinic; and a designer of a deep learning network aimed at giving pharma and healthcare companies a handle on their data.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
Approximately 1,000 jobs will be eliminated at H. Lundbeck A/S (LUN.CO) as the psychiatric drugmaker faces increased competition from generic medications, the Danish company announced this morning. Kåre Schultz, Lundbeck’s new chief executive officer, said the company’s new restructuring program will improve its fiscal position so it can “invest in future profitable growth initiatives.” Schultz, […]
AbbVie Inc has bought a priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs. United Therapeutics received a rare pediatric disease priority review voucher in March after its drug, Unituxin, was approved by the U.S. Food and Drug Administration to […]
The first drug to treat low sexual desire in women won approval from U.S. health regulators on Tuesday, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol. The U.S. Food and Drug Administration said the pink pill, to be sold under the brand name […]
Amgen Inc. reached a $71 million settlement with 48 states related to allegations that the biotechnology company made unsubstantiated marketing claims about blockbuster drugs Aranesp and Enbrel, according to several state attorneys general. In a statement on Tuesday, Amgen said the settlement with the states resolves some of the same issues addressed in Amgen’s December […]
Merck & Co. (MRK) has its eyes set on eliminating another 2,500 jobs as part of its ongoing restructuring plan announced in 2013, according to a recent filing with the U.S. Securities and Exchange Commission. According to the filing, the company said “approximately 2,585 position eliminations remain pending under this program as of June […]
Ann Arbor, Mich.-based Esperion Therapeutics, Inc. (ESPR), announced yesterday that the U.S. Food and Drug Administration (FDA) confirmed LDL-C as an acceptable clinical surrogate endpoint for its trial therapeutic, ETC-1002. ETC-1002 is designed to lower cholesterol for patients who have not had success using statins, such as Pfizer Inc. (PFE)’s Lipitor. The compound is […]
Gene-sequencing giant Illumina Inc, private equity firm Warburg Pincus LLC and venture capital firm Sutter Hill Ventures have agreed to invest $100 million to seed a new consumer-facing human genome platform called Helix, according to people familiar with the deal. San Francisco-based Helix aims to provide a new kind of environment that will sequence, store […]
Manufacturers of medical devices linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning letters to the companies released on Monday. The letters, sent on Aug. 12, cite Olympus Corp Pentax Medical and Fujifilm Holdings Corp with multiple violations […]
The death of a patient participating in a Kite Pharma, Inc. (KITE) clinical trial was determined to not be related to the experimental treatment for low-prognosis patients with non-Hodgkin’s lymphoma, Arie Belldegrun, Kite’s chief executive officer said in a conference call this morning. During the conference call, Belldegrun refuted what he called a “high […]