News

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

The company will manufacture a conjugated vaccine candidate being developed to prevent the disease melloidosis.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

The agreement will fund the late-stage clinical development, a Phase III clinical trial, large-scale manufacturing, and the delivery of 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

The agreement will combine Rentschler’s experience in drug substance manufacturing and Vetter’s expertise in aseptic fill/finish and secondary packaging.

Emergent is entering into a five-year agreement with Janssen Pharmaceuticals for the large-scale drug substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine, Ad26.COV2-S.

Lonza is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

The new Uhlmann bottle line uses Cremer technology for 100% counting accuracy and an inspection and rejection system for all critical quality parameters.

The new Uhlmann bottle line uses Cremer technology for 100% counting accuracy and an inspection and rejection system for all critical quality parameters.

While there currently is no molecular therapy targeted against the PAUFgene, Prestige believes its monoclonal antibody has the potential to benefit patients affected by PAUF-positive pancreatic cancer.

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.

Vertex Pharmaceuticals has announced that it has extended its agreement with the National Health Service (NHS) England for its cystic fibrosis medicines.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.

Industry veteran Loewald tapped to head CDMO Cambrex.

Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit-a deep tech company-and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research.

The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.

The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.

As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.