September 26, 2016

Amjevita is the fourth approved biosimilar in the United States, and Amgen’s first approved biosimilar. 

September 23, 2016

The company announced Tuesday that its board of directors had named Paul Campanelli to the position, effective immediately, succeeding Ravid De Silva, who has stepped down from the position and his place on the company's board of directors. 

September 22, 2016

This is the first approval for a generic of Tivicay (dolutegravir), an HIV treatment recommended by the World Health Organization and the Centers for Disease Control and Prevention. 

 
September 22, 2016

Impax’s generic will be available in 10-, 20-, 30-, 40-, 50- and 60-mg dosage strengths.

September 21, 2016

ATLANTA - The total economic burden attributed to opioid abuse exceeds $78 billion, according to a recent report published in Medical Daily. "More than 40 Americans die each day from overdoses involving prescription opioids. Families and communities continue to be devastated by the epidemic of prescription opioid overdoses." Tom Frieden, director Centers for Disease Control Director shared with Medical Daily. "The rising cost of the epidemic is also a tremendous burden for the health care system." (Medical Daily)

September 20, 2016

As drug costs again become a topic of national conversation, Chip Davis, president of the Generic Pharmaceutical Association, has weighed in on the issue. 

September 20, 2016
BioPharmaDIVE is reporting on a recently filed lawsuit from Sanofi contending that Merck & Co. infringed on its patents for Lantus (uinsulin glargine) and its insulin delivery device soloSTAR. The lawsuit follows Merck’s announcement that it had filed a New Drug Application with the Food and Drug Administration for follow-on biologic insulin glargine product. It has previously sued Eli Lilly & Co., alleging that its insulin biosimilar infringed on its patents, which delayed the launch of Lilly’s Basalgar until December. (BioPharmaDIVE)
 

 

September 19, 2016

The drug had about $22.5 million in U.S. sales for the 12 months ended July 2016, according to IMS Health

September 19, 2016

Both the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization issues statements in support of the letter.

September 15, 2016

The drug had about $1.2 billion in U.S. sales as of July 2016, according to IMS Health data.

September 14, 2016

Seven out of 10 U.S. adults ages 65 and older have high blood pressure (140/90mmHg or higher), but nearly half do not have their blood pressure under control.

September 13, 2016

A new report from the U.S. Government Accountability Office, prices on generics under Medicare Part D decreased overall between 2010 and the end of 2015.

September 13, 2016

USA Today is reporting that two senior officers at Taro Pharmaceuticals have been subpoenaed by the Department of Justice, which is seeking generics pricing and sales documents, according to a Securities and Exchange Commission disclosure the company filed Friday night. Taro did not identify which executives had been subpoenaed, but said it “intends to respond to the subpoena and otherwise cooperate with the Department of Justice investigation." (USA Today)

September 12, 2016
Amneal’s launch expands its women’s health line to six products.
September 9, 2016

A new update to the mobile app for the Merck Manual for Healthcare Professionals is broadening access to the reference guide. 

September 6, 2016

Brand and generic sales of the drug were $109.6 million for the 12 months ended July 2016, according to IMS Health.

September 6, 2016
Annual sales for the product were $379 million for the 12 months ended July 2016. 
 
September 6, 2016

Lupin’s Avelox generic will be available in 400-mg dosage strength.

August 31, 2016

The new version of GDUFA includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications

August 31, 2016

Among the changes, the FDA is requiring boxed warnings for nearly 400 products, as well as patient-focused Medication Guides for prescription opioids and benzodiazepines.

August 30, 2016

Two recent unanimous approval recommendations from FDA advisory committees regarding biosimilars is a signal of growing scientific acceptance and understanding of the biosimilar regulatory pathway, suggested The National Law Review in a report Tuesday. The National Law Review has created a chart summarizing pending and approved BLAs for biosimilars using publicly available information, the publication noted, but there are still two barriers to entry. As biosimilars gain FDA approval, patent issues remain a barrier and the exorbitant R&D cost prevent significant price disparities. Accordingly, insurers may be slow to add biosimilars to the formulary, The National Law Review suggested. (The National Law Review)

August 30, 2016

The steps Teva Pharmaceuticals  had to take to win antitrust approval for its $40.5 billion acquisition of Allergan's U.S. generics business are attention grabbing, TheStreet reported earlier this week - securing approval from the Federal Trade Commission took 12 months and required the divestiture of nearly 80 drugs. "Deal makers in the generics space should take note the FTC went beyond the traditional focus on head-to-head competition between drugs on the market and potential competitors in the R&D pipeline," TheStreet wrote. "The commission also considered three new theories of competitive harm, including whether buyers will gain pricing power by bundling drug portfolios, whether generic drug makers will have less incentive to challenge brand drug patents and whether the merger will reduce the number of players in hard-to-make complex generics." (TheStreet)

August 29, 2016

Mylan expects to launch first generic to EpiPen Auto-Injector in several weeks, pending completion of labeling revisions.

August 26, 2016

Upsher-Smith's new partnership is aimed at marketing and distributing a generic central nervous system product.