Industry News

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

Biden outlines a plan to end the pandemic in a virtual global conference.

The first part of the 2021 CPhI Annual Report has been published and predicts a strong outlook for CDMOs over the next few years.

The organizers of Pharmapack Europe have released the results of its global drug delivery and packaging survey, demonstrating the continuation of the United States’ lead in innovation.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.

Verrica Pharmaceuticals receives CRL from FDA identifying deficiencies at a facility of a CMO for its NDA for VP-102.

The FDA has amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow a single booster dose to several high-risk populations.

US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.

The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.

Apellis Pharmaceuticals has announced the top-line results from two Phase III studies, evaluating intravitreal pegcetacoplan as a treatment for geographic atrophy.

Exscientia has entered into a four-year agreement with the Bill & Melinda Gates Foundation for the development of small-molecule therapeutics that can tackle coronavirus and other viruses with pandemic potential.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

ABPI has announced that eight leaders from the patient and health charity sector have been chosen to join its new Patient Advisory Council.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

Sterling Pharma Solutions has invested in a center of excellence for research into commercial applications of continuous flow chemistry at its site in Dudley, UK.

Nanoform and Herantis Pharma's proof of concept project evaluating the application of the nanoforming process has been successful.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.

The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.

FDA will now require new and updated warnings about the increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.