Drugs

The move allows for the purchase of 900 million doses of the companies’ current mRNA-based vaccine and of a vaccine adapted to variants, with the option to purchase an extra 900 million shots. The contract stipulates that the vaccine production is based in the EU and that essential components are sourced from the EU; it

The Massachusetts-based biotech is developing synthetic live bacterial therapeutics using tools and components including a proprietary library of synthetic biology parts. As Synlogic is manufacturing live bacteria, its production process differs from those used to make traditional biologics.  Synlogic invested in its internal capabilities to handle the novel modality, establishing both lab-scale production capabilities to

PRINCETON, N.J.–(BUSINESS WIRE) May 20, 2021 — Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).1

BioHale Sucrose is part of its new portfolio, BioHale, targeted at the biopharmaceutical manufacturing industry; the product, said to be low in endotoxin levels, looks to provide purity stabilization for biologics.  Bas van Driel, CEO, DFE Pharma © DFE Pharma Excipients of high purity with low endotoxin levels are needed for the manufacture of injectable

The purchase price is expected to be US$292.5m in cash, said Charles River. The deal, which is anticipated to close at the beginning of Q3 this year, also includes contingent additional payments of up to US$57.5m, based on future performance. It is subject to the customary regulatory requirements and closing conditions. Vigene, said the CRO,

Erelzi (etanercept-szzs) was approved by the FDA in August 2016. However, Sandoz has been unable to launch the drug in the US due to the patent litigation from Amgen covering the active ingredient in Enbrel. The US Court of Appeals for the Federal District in July 2020 ruled against Sandoz, upholding a prior ruling from

May 17, 2021 Audience: Consumers May 17, 2021 — Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary recall of Durisan Non Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Burkholderia contaminans, generally considered to be

The investigational COVID-19 vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines, along with GSK’s established pandemic adjuvant technology. The drug companies had hoped to have regulatory approval for their jab in the first half of this year, but interim results from a Phase 1/2 study, released in December 2020,

Organic growth at Merck’s process solutions business hovered around 15% in the year preceding the pandemic. Demand for products used in the production of COVID-19 vaccines and therapies began to accelerate growth last year, but “pinch points”​ in the supply chain constrained the unit. Merck has invested €380m ($461m) in the past 12 months to

Multiple studies have found continuous bioprocessing reduces commercial cost of goods (COG) by between 10% and 30%, largely because the approach enables smaller manufacturing trains and the implementation of single-use technologies at those reduced scales. However, the effect of continuous bioprocessing on process development, which with clinical manufacturing is estimated to account for 17% of

Doug Hausner, senior manager, continuous manufacturing business development, Pharma Services, Thermo Fisher Scientific, said such hurdles, among others, makes partnering with established vendors or CDMOs particularly important as the business case and associated timelines for the continuous manufacturing platform often will not work for a single product, and the decision to adopt the technology should

The Le Mans site has already benefitted from significant investment. Now, to support further growth and to sustain the increase in both clinical and commercial production capacity at the facility, the contract development and manufacturing organization (CDMO) is investing more than €4m (US4.84m) in the site, with it also set to boost employees numbers there;

Consequently, extending the administration of a second dose to 12 weeks could potentially enhance and extend antibody immunity, say the authors – and could even reduce the need for booster shots. The Pfizer/BioNTech vaccine’s Phase 3 trials were based on 3 weeks between doses: a gap maintained for mass vaccination campaigns some countries like the

The contract covers 25m doses in total. Moderna will provide the Australian government with 10m doses of mRNA-1273, its existing vaccine against the ancestral coronavirus strain, this year and go on to ship 15m doses of its updated variant candidate in 2022. Moderna shared initial data from a midphase trial of a vaccine designed to

As the end of the Brexit transition period approached last year, the MHRA released draft guidance on the licensing of biosimilars for consultation. The draft document was based on the European Medicines Agency (EMA) guidelines that applied in the UK before Brexit, but it diverged from those foundational texts in some areas. In describing the

Talking to investors on a first quarter results conference call in mid-April, Joachim Kreuzburg, CEO of Sartorius, discussed whether COVID-19-related demand was at its peak. Kreuzburg estimated that the annual run rate was up to 5bn vaccines a year, leading him to argue that demand is at least close to its peak. “I do not

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH) WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Empaveli™ (pegcetacoplan), the first and only targeted C3 therapy

Named J.POD 2EU, the site will use tech from Evotec subsidiary Just-Evotec Biologics: which utilizes small, automated, highly intensified and continuous bioprocessing operations housed inside autonomous cleanrooms. Construction of the €150m ($181.8m) site will start in H2, 2021. Once operational in 2023, it will be able to product therapeutic antibodies, including those related to infectious

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain SAN DIEGO, May 13, 2021 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food