Drugs

KENILWORTH, N.J.–(BUSINESS WIRE) May 5, 2021– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive

In February, Pfizer was predicting $15bn in COVID-19 vaccine sales for this year. Fast-forward just three months and the pharmaceutical giant has now revised that figure up 70% to $26bn. That would mean the vaccine would account for nearly 30% of overall revenues in 2021. And the $26bn figure is based on 1.6 billion doses ordered

Additional production lines will come online sequentially, said the contract development and manufacturing organization (CDMO). All three are expected to be operational in the earlier part of 2022 In May 2020, Lonza and Moderna announced a 10-year strategic collaboration agreement to enable the manufacture of Moderna’s COVID-19 vaccine and additional products from the US biotech in

The non-exclusive partnership will result in the integration of Ori’s proprietary CGT manufacturing platform’s data architecture with ATMPS’ Hataali, a secure data sharing platform, specially designed as a scalable system for advanced therapies. The combination of the two proprietary platforms is aimed at providing improved product tracking, scheduling as well as live monitoring of the

April 30, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy April 30, 2021 — Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled

Sanofi will use its Ridgefield, NJ facility to perform fill and finish of the doses, starting in September. “Since the beginning of the pandemic, we have been mobilizing on multiple fronts and we showed solidarity across the industry”,​ said Paul Hudson, Chief Executive Officer, Sanofi. “We are one of the few pharmaceutical companies to leverage many industrial partnerships to improve​ global supply and access to COVID-19 vaccines, while in parallel,

May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia – BOSTON, May 1, 2021 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today

The tech – which the company has honed over years with its influenza vaccine candidate – uses plants to produce protein particles for the vaccine. If authorized, the COVID-19 vaccine will become the company’s first commercial product. Plants as ‘mini protein factories’​ Founded in 1999, Quebec City’s Medicago is a pioneer of plant-derived therapeutics. Its

FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose LONDON, April 30, 2021 /PRNewswire/ — Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the emergency treatment of known or suspected opioid overdose,

30 April 2021 Approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years In DAPA-CKD Phase III trial, Farxiga demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death  AstraZeneca’s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2)

The company also expects to increase 2021 supply to between 800 million and 1 billion doses. Today’s announcement, alongside other news from fellow mRNA heavyweights Pfizer/BioNTech this month, illustrates how companies and governments are starting to plan for mass supplies of COVID-19 vaccines over the longer term. Longer term plans start to come into focus

A trial participant treated with a single intravitreal injection of a high dose of the company’s ADVM-022 treatment has developed hypotony [increased pressure in the eye], with panuveitis [major inflammation of the eye] and loss of vision in the treated eye. Following that discovery, Adverum said that, in the interests of patient safety, it had decided

AD is the most prevalent cause of dementia and, currently, there is no effective treatment. Led by Dr Jonathan Kipnis, professor of pathology and immunology at Washington University School of Medicine, working with PureTech scientists, the study​​ suggests that enhancing meningeal lymphatic drainage could improve clinical outcomes in AD, either alone or in combination with passive

Are decentralized trials fast becoming the new norm? Top of mind for Rob Church, a pharmaceutical and biotechnology regulatory law expert at US firm, Hogan Lovells, is the future of clinical studies, particularly in light of the decentralized clinical trial (DCT) trend seen over the past year. The pandemic has been the catalyst in speeding

The two companies first initiated collaboration back in February 2018. This expanded contract is worth US$50.3m to Samsung, a near US$30m increase on the original US$22.4m CMO deal, a spokesperson for the Korean CDMO told BioPharma-Reporter.  Michael S Weiss, CEO of TG Therapeutics, said the partnership with Samsung will ensure stable supply of ublituximab as

The financial outlay has enabled part of the facility to be dedicated to the safe handling of cell and gene therapy (CGT) samples, including the installation of cryogenic storage, allowing biological materials such as cell therapies to be preserved in liquid nitrogen vapor at temperatures of around -180°C, said the CDMO.  The facility also has the

The CD19-targeted antibody drug conjugate (ADC) was granted accelerated approval by the US regulator based on overall response rate. The approval also covers patients with DLBCL arising from low grade lymphoma and high-grade B-cell lymphoma. “This is the first ever approval of a PBD based ADC,”​ noted Chris Martin, CEO, ADC Therapeutics, on a conference

The European Commission accuses AstraZeneca of a breach of contract over COVID-19 vaccine deliveries. The announcement follows months of spats as Europe seeks to protect its vaccine supplies: such as mounting export controls​​ and inspecting factories for extra supplies.​​   ‘Best reasonable efforts’ AstraZeneca was due to deliver 180 million vaccines doses to the EU