October 28, 2016
Bloomberg BNA is reporting that the Food and Drug Administration’s director of the Center for Drug Evaluation and Research’s Office of New Drugs told an audience at the DIA Biosimilars Conference that manufacturers looking to submit an application for biosimilar approval should know what the FDA is looking for when evaluating a biosmilar for approval. Jenkins said that rather than the focus on safety and efficacy it places on standalone biologics, with biosimilars, it focvuses on how closely it resembles the reference product, something he called “a work in progress” for some drug makers. (Bloomberg BNA)
 
October 27, 2016

NEW YORK - The giant AT&T-Time Warner merger may bring individualized ads - already commonplace on such streaming services as Hulu or YouTube - to network television, The New York Times reported Wednesday. "If you believe in a future where the very, very fine targeting of households or individuals with specific messaging makes economic sense to do at scale, what this merger does is enable that by making more audience available to target in that way,” Rob Norman, chief digital officer of WPP's GroupM, told The Times. “The question will be: What is the premium for addressability for that level of targeting that the advertiser is willing to pay?” (The New York Times)

October 26, 2016

Dr. Reddy’s Laboratoreis and Gland Pharma have announced a strategic collaboration to market and distribute eight injectable generics. 

October 26, 2016

Aurobindo’s generic will be available in 1-, 2- and 3-mg dosage strengths. 

October 26, 2016

Among the reasons for the  name change was the organization’s expansion beyond its founders’ focus on biotechnology. 

October 25, 2016

ANI’s benztropine mesylate tablets will be available in 0.5-, 1-, and 2-mg dosage strengths. 

October 25, 2016

Genco’s multi-tenant warehouse solution allows multiple manufacturers to operate alongside one another in a single warehouse, using a designated space with a shared technology platform. 

 
October 25, 2016

Generic Pharmaceutical Association SVP sciences and regulatory affairs David Gaugh outlined the goals of GPhA and the FDA in negotiations over the second iteration of GDUFA at a public meeting on Oct. 21.

October 25, 2016

The FDA’s proposal to withdraw approval allows the company to request a hearing, though it only has until Nov. 17 to do so. 

October 25, 2016

Vanda and Taro have entered a license agreement delineating when Taro's generic of Vanda's Fanapt can enter the market. 

October 24, 2016

The Generic Pharmaceutical Association (GPhA) announced Monday that Jeffrey K. Francer will be joining the organization as SVP and general counsel starting Nov. 14. 

October 21, 2016

The company will be making 160,000 drug deactivation pouches to families at nearly 800 Walmart stores in Indiana, Kentucky, Ohio, Pennsylvania, South Carolina, Tennessee and West Virginia.

October 19, 2016

Camber Pharmaceuticals announced Wednesday that its parent company, Hetero Drugs, has been recognized by Gilead Sciences for its work providing access to hepatitis C drugs for patients worldwide.

October 19, 2016

The report, compiled on behalf of the Generic Pharmaceutical Association, found that in 2015, generic drugs brought patients and the U.S. healthcare system 227 billion in savings, bringing the savings since 2005 from generics to $1.46 trillion. 

October 18, 2016

Amneal’s Yuvafem delivers the same low dose of vaginal estrogen as Vagifem, and is packaged in 8- and 18-count sizes. 

October 18, 2016
Inflectra will be the second biosimilar available in the United States, and the first biosimilar monoclonal antibody. 
October 18, 2016

Forbes is reporting that that Lannett’s shares fell 12.9% on Monday following an announcement from the FDA that it would be withdrawing approval of Lannett’s Concerta generic. The drug treats attention deficit hyperactivity disorder, and the FDA said there might not be enough evidence that Lannett’s generic is bioequivalent to the reference product. (Forbes)

October 18, 2016

The portfolio Upsher-Smith acquires contains 19 solid-oral dosage products and one nasal product, all of which have been approved by the Food and Drug Administration but haven’t been marketed by Sandoz.

October 17, 2016

Drug overdoses have become the leading cause of accidental death in the United States, with 47,055 people dying in 2014 as a result of lethal drug overdoses — 18,893 of which were related to prescription pain relievers. One of the critical first lines of defense, the drug naloxone can reverse the effects of an overdose. But until recently it could only be accessed by prescription.

October 13, 2016

The Dr. Reddy’s generic will be available in 2-, 5-, 10-, 15-, 20- and 30-mg dosage strengths in 30-count bottles.

October 13, 2016

The HDA seminar will host supply chain leaders — including distributors, manufacturers, pharmacists and third-party logistics providers — as well as federal/state regulators.

October 13, 2016

Beyaz had U.S. sales of about $134 million for the 12 months ended August 2016, according to IMS Health data. 

October 12, 2016
The drug had $133 million in U.S. sales for the 12 months ended July 2016, according to IMS Health. 
 
October 10, 2016

The Dr. Reddy’s generic will be available in 25-, 50-, 100- and 200-mg dosage strengths in 30-count bottles.