Top News

FDA approved 45 novel new drugs in 2015, led by therapies for orphan diseases and and expedited approvals.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

The National Institutes of Health released a strategic plan covering the fiscal years 2016-2020.

The new arrangement draws from a consignment approach, in which Walgreens will sell-but not directly own-Valeant’s products.

The company will in-license a novel antibody, which has a conformation that is associated with increased therapeutic efficacy.

An FDA panel recommended approval of Teva’s monoclonal antibody, reslizumab.

Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.

The Committee on Energy and Commerce met to assess influenza vaccine effectiveness, and changes for the 2015-2016 season.

The deal to acquire Allergan will cost Pfizer $160 billion, and if the merger does not go through, CNBC reports the break-up fee would be $3.5 billion. The amount of the termination fee was calculated in advance of any further restrictions on tax inversion deals, however.

FDA seeks industry support for metrics program, emphasizing the surveillance focus.

The proposed merger of Pfizer and Allergan will create a new top drug maker and cut Pfizer’s tax bill with a headquarters move to Ireland.

Global spending on medications will continue to rise, and it is expected to increase by $349 billion on a constant-dollar basis by 2020-more than $150 billion more than it increased during the past five years, according to a new IMS Institute for Healthcare Informatics report, Global Medicines Use in 2020: Outlook and Implications. Although the spending increase is large, total spending on medicines is expected to increase at a slower rate than it did over the past five years, when spending on medicines increased approximately 35%.

AstraZeneca has agreed to acquire ZS Pharma for $2.7 billion, according to a press release from AstraZeneca. 

The company terminates its relationship with mail-order pharmacy Philidor Rx Services after allegations of improper accounting surface.

Valeant faces increased scrutiny for allegedly using its in-house mail-order pharmacy, Philidor, to keep drug prices artificially high.

Senator McCaskill deemed J. Michael Pearson’s response letter on drug pricing “inadequate.”

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

Researchers in the US, Japan, and China are recognized for developing therapies to combat river blindness, lymphatic filariasis, and malaria.

The National Biologics Manufacturing Centre will provide companies with open access to bioprocessing facilities and expertise to expedite low-risk market entry of complex biologics.

Democratic members of the House Committee on Oversight and Government Reform are requesting a subpoena for documents withheld by Valeant Pharmaceuticals.

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

A drug price hike like that of the one seen in the highly publicized case of Turing Pharmaceuticals' Daraprim is prompting a public outcry and is demonizing the industry for those who see Martin Shkreli as representative of all pharmaceutical executives. But capping drug price increases may affect actual patient costs less than imagined, and may have a bigger impact on pharmacy benefit managers and insurance companies.

Hillary Clinton unveiled a new plan on Sept. 22 during a community forum in Des Moines, Iowa to tackle high drug prices. The plan reveal was a follow-up to a tweet from the presidential candidate a day prior, on Sept.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.