Top News

Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.

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.

The increase in spending is said to be due to increased access to and use of medicines in emerging markets and higher prices for branded, specialty medications in developed markets.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.

Roche will invest in Switzerland but leave sites in Ireland, Spain, Italy, and the US as it focuses on lower-volume, specialized medicines.

AstraZeneca’s solid-dose facility in Taizhou, China received ISPE’s FOYA 2015 Overall Winner award.

AstraZeneca will add ZS Pharma’s leading ion-channel candidate to its pipeline.

The latest revisions to the international pharmacopoeia standards for glass pharmaceutical packaging have emphasized the importance of assessing delamination propensity of pharmaceutical glassware, including bottles, vials, cartridges, and syringes.

GEA has entered into a collaboration with GSK to further develop self-contained, POD-based mini-factories for the manufacture pharmaceutical oral solid dosage forms.

Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.

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

This year, experts took on topics ranging from innovation to market access and the impact of mega trade pacts.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

Merck relaunches brand identity to reflect transformation into a science and technology company.

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.

Stefan Oschmann will replace new Karl-Ludwig Kley as chairman of the executive board and CEO of Merck KGaA.

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.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

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

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

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

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Intuniv (guanfacine hydrochloride prolonged-release tablets) is the first selective alpha-2A adrenergic receptor agonist licensed for the treatment of attention deficit hyperactivity disorder in Europe.

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.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.