July 13, 2016
Reuters is reporting that the FDA’s Arthritis Advisory Board has unanimously recommended Amgen’s biosimilar of AbbVie’s Humira, ABP 501. The panel said that the drug was similar in safety and effectiveness to Humira for rheumatoid arthritis and plaque psoriasis, and it recommended that the biosimilar should also be approved for Crohn’s disease in adults and ulcerative colitis. (Reuters)
July 12, 2016

The agency has acted on 90% of the generic drug and prior approval supplement applications pending as of Oct. 1, 2012 — which puts it more than a year ahead of its final deadline of Sept. 30, 2017. 

July 12, 2016

The move is aimed at Nichi-Iko becoming one of the top 10 global generics leaders, and the companies said acquiring Sagent will boost Nichi-Iko’s ability to commercialize its biosimilar pipeline and increase its presence in injectables.

July 6, 2016

Mylan’s fenofibrate tablets will be available in 40- and 120-mg dosage strengths. 

July 5, 2016

For the quarter, the company saw revenues of $723.6 million — a 1.6% rise over the same quarter last year that it attributes to overall market growth and the expansion of its franchised store network.

July 1, 2016
NACDS and NCPA urged the Senate committee to adopt the House’s position in its version of the National Defense Authorization Act , which does not include provisions that would increase TRICARE copays, arguing that higher copays can have detrimental effects on patient health and federal spending. 
 
June 30, 2016

Toohey is the former president and CEO of the Semiconductor Industry Association, where he oversaw that industry’s federal advocacy, international trade and technology programs, as well as a veteran of PhRMA’s advocacy team. 

June 29, 2016

The Consumer Healthcare Products Association has published a case study regarding efforts to curb teen abuse of over-the-counter cough medicine containing dextromethorphan. 

June 28, 2016

Health care is local. But the back-end service that enables the delivery of that localized healthcare experience has become increasingly global both in size and scope.

June 28, 2016

Prasco Laboratories has entered into agreements with Teva and Shire to acquire the rights to distribute the generic version of Adderall XR Extended Release Capsules.  

June 27, 2016

Mylan announced Monday that it has launched Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's Avodart Capsules, in the U.S.

June 27, 2016

Pharmasave announced that its pharmacists have been trained to be leaders in providing medication therapy management programs.

June 27, 2016

The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would amend the Public Health Service act to change the exclusivity period from 12 years to seven years. 

June 24, 2016

The drug is indicated to treat mild to moderate active and in remission Crohn’s disease in the ileum and/or ascending colon. 

June 23, 2016

Specifically, CMS' proposed guidance would standardize the reporting by PDP sponsors of price concessions received from, and incentive payments made to, participating network pharmacies.

June 23, 2016

Nonalcoholic steatohepatitis (NASH), a fatty liver disease, affects about 2% to 5% of the U.S. population and doesn't currently have an approved treatment. 

June 22, 2016

Headquartered in New York, Snow Phipps has overseen the deployment of over $1.7 billion of private equity capital and co-investments in 17 platform investments and over 25 add-on acquisitions since inception.

June 22, 2016

The bill was met with praise from several industry groups when it was introduced, and a Generic Pharmaceutical Association member testified at the hearing. 

June 21, 2016

The $586 million acquisition will add products in solid, oral, injectable, inhalable and topical drugs, including 15 currently marketed products, to Impax's portfolio. 

June 21, 2016

Modern Healthcare is reporting on the recently handed down Supreme Court decision in Cuozzo Speed Technologies v. Lee, which might make it easier for generic drug makers to manufacture generics, but could also make it difficult for companies to protect their patents. The decision allows the Patent and Trademark Office's board for patent trial and appeal to use a broad standard when interpreting patent claims. The Generic Pharmaceutical Association Monday called the decision "one that promotes a competitive, affordable prescription drug market for consumers." (Modern Healthcare)

June 15, 2016

The pilot program, which in effect would allow the DoD to access lower pricing for prescriptions dispensed at community pharmacies, is included in the version of the NDAA passed by the House on May 18, but not in the version passed by the Senate June 14.

June 14, 2016
The drug will be available from Ajanta in 5- and 10-mg dosage strengths. 
June 14, 2016

Since 1959 the DIANA awards have honored HDA-member manufacturers that develop innovative new product introductions and promotions for the healthcare distribution industry.

June 13, 2016

In addition to receiving FDA approval for its generic of Trileptal, ANI Pharmaceuticals has launched its 5-mg dosage strength oxycodone.