Top News

The IMS Institute for Healthcare Informatics report examines spending on medicine in the US, drivers of growth, major market segments, prescription volume, patient costs, and healthcare delivery changes.

Cornell researchers reveal that an existing FDA-approved drug can facilitate the delivery of other large molecules across the blood-brain barrier.

Inflectra is the second biosimilar to hit the market in the United States.

The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Adheren relies on chemical modifications, rather than genetic engineering, to create its cell-based immunotherapies.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

Sir Andrew Witty, CEO of GlaxoSmithKline, has said that he plans to retire from the company in March 2017, after nearly ten 10 years in the position.

With a new name formed from the legacy company names, Alcami offers development services, analytical testing, and API and finished drug development and manufacturing.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

Robert Califf has been confirmed by the US Senate as FDA commissioner.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

On Feb. 9, 2016, an FDA Arthritis Advisory Committee will meet to discuss a biologics license application (BLA) for CT-P13 (Remsima), a proposed biosimilar to Janssen Biotech's Remicade (infliximab), by South Korea’s Celltrion in partnership with Pfizer. The BLA was submitted via the abbreviated 351(k) pathway and seeks to cover all of the eight indications that are approved for Remicade.

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

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.