Pharma & Biotech Pricing, Policy & Regulation
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
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Pharmaceutical
Shares in US biopharma Axsome Therapeutics, a biopharmaceutical company developing and delivering novel therapies for the management of CNS disorders, closed 7% higher on Wednesday. 5 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Biotechnology
The Cell and Gene Therapy Catapult (CGT Catapult) has highlighted what it regards as the UK's potential to lead the global cell and gene therapy sector. 5 September 2024
Pharmaceutical
MHRA has concluded that the available evidence does not establish a causal relationship between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal behavior, suicidal ideation, self-injury and depression. 4 September 2024
Pharmaceutical
Gedeon Richter today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a license for Ryeqo (relugolix 40mg, estradiol 1mg, and norethisterone acetate 0.5 for the symptomatic treatment of endometriosis 4 September 2024
Biotechnology
EC approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for urothelial carcinoma in adults. 3 September 2024
Biotechnology
The budget on October 30 is an opportunity to end short-termism, cut waste, and attract long-term investment to the country’s economy with a sector-targeted R&D tax relief policy, according to the UK BioIndustry Association (BIA). 3 September 2024
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized mRNA specialist Moderna’s updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. 3 September 2024
Pharmaceutical
The Danish Pharmaceutical Industry Association, Lif, has given its verdict on the government financial bill setting out new priorities in health in 2025. 2 September 2024
Pharmaceutical
Research from AARP has found that around $1,100 in prescription drug costs could be saved by more than a million seniors, due to the Inflation Reduction Act (IRA). 2 September 2024
Biotechnology
Chinese biopharma Hutchmed on Friday announced that it has voluntarily withdrawn its supplemental New Drug Application (NDA) in China for fruquintinib. 2 September 2024
Pharmaceutical
Regulatory news last week included European Commission approval for Swiss drugmaker Basilea’s antibacterial Cresemba, triggering a milestone payment from partner Pfizer. On the research front, Neurocrine Biosciences released mixed results from a Phase II study of its NBI-1117568 as a treatment for schizophrenia. Also, Alnylam Pharmaceuticals reported new Phase III data on its vutrisiran in cardiomyopathy. Swiss pharma giant Novartis inked collaboration with Lindy Bioscience aiming to turn biologic drugs into at home injectables, US major Eli Lilly launched a single vial formulation of its fast selling obesity drug Zepbound at a price discount of around 50% compared with other GLP-1 medicines. 1 September 2024
Biotechnology
Pierre Fabre Laboratories has announced that the European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. 30 August 2024
Biotechnology
Emergent BioSolutions’ shares were up 16.44% at $10.37 pre-market on news of US regulatory clearance of its mpox vaccine. 30 August 2024
Pharmaceutical
The UK government has unveiled a £400 million ($530 million) investment program aimed at enhancing clinical trials and accelerating access to new treatments through the country’s national healthcare provider. 30 August 2024
Biotechnology
Johnson & Johnson said yesterday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking the first approval of nipocalimab. 30 August 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it is seeking views from interested stakeholders on proposals to update its statutory fees to ensure they continue to recover their costs. 30 August 2024
Pharmaceutical
The European Commission has authorized GSK's (LSE: GSK) Arexvy (respiratory syncytial virus vaccine) for preventing lower respiratory tract disease caused by RSV in adults aged 50-59 with underlying health conditions. 30 August 2024
Biotechnology
Marseille-based ImCheck Therapeutics has received 20.2 million euros ($22.4 million) in non-dilutive funding as part of the i-Démo call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government. 29 August 2024
Pharmaceutical
A workshop held at the International Association for the Study of Pain (IASP) World Congress has revealed significant discrepancies in clinical practice guidelines (CPGs) across countries for opioid use in chronic pain management. 29 August 2024
Pharmaceutical
SIGA Technologies (Nasdaq: SIGA) has announced a significant procurement option exercised by the US health authorities, an order for $113 million worth of oral Tpoxx (tecovirimat). 23 July 2024
Biosimilars
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
Pharmaceutical
The Organization of Pharmaceutical Producers of India (OPPI) has urged the government to exempt patented and orphan drugs from price control. 22 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
Biotechnology
A recent draft report from the Institute for Clinical and Economic Review (ICER) has evaluated the cost-effectiveness of therapies for transthyretin amyloid cardiomyopathy (ATTR-CM), warning that in some cases, the price is too high. 22 July 2024
Pharmaceutical
Last week, US healthcare giant Johnson & Johnson kicked off the second-quarter financial reporting period, posting better than expected results and raising its full-year forecast. The USA’s Biomedical Advanced Research and Development Authority (BARDA) recently announced that it has committed up to $500 million to fund next generation COVID vaccines. US biotech Caribou Biosciences said it is refocusing its research and cutting back its workforce. Also of note, Roche subsidiary Genentech terminated its collaboration with US precision medicines company Relay Therapeutics on migoprotafib. 21 July 2024
Generics
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday approved the first generic raltegravir medicines to treat adult and pediatric HIV patients 20 July 2024
Biosimilars
Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab. 19 July 2024
Pharmaceutical
The National Institute for Health and Care Excellence’s (NICE), the cost-effectiveness watchdog for England and Wales, has published a Final Appraisal Document recommending the reimbursement of Orgovyx (relugolix) in prostate cancer. 19 July 2024
Pharmaceutical
French drugmaker Sanofi (Euronext: SAN) is reportedly planning a significant investment of over $400 million in its “global capacity center,” in Hyderabad, India. 19 July 2024
Pharmaceutical
Ardelyx has filed a lawsuit against the US Department of Health and Human Services DHSS) and the Centers for Medicare and Medicaid Services (CMS), regarding its Xpohzah. 19 July 2024
Pharmaceutical
Ono Pharmaceuticalannounced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for vimseltinib. 19 July 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10 mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD). 18 July 2024
Biosimilars
Privately-held German drugmaker Boehringer Ingelheim has inked a deal with GoodRx (Nasdaq: GDRX), in a bid to boost US penetration of its biosimilar to Humira (adalimumab). 18 July 2024
Pharmaceutical
60% of listed Indian pharmaceutical companies have experienced an uptick in new business inquiries from US pharma companies due to the discussions around the US Biosecure Act. 18 July 2024
Pharmaceutical
A new research paper concluding that the use of Inpefa (sotagliflozin) for the treatment of patients hospitalized for heart failure (HF) and suffering from co- morbid diabetes leads to significant positive impact on provider health system financial outcomes. 18 July 2024
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday announced it has approved two new medicines for use in Great Britain. 18 July 2024
Pharmaceutical
Trade association has called on the authorities of Russia to make adjustments for the methods of calculation of the initial maximum price of contracts (IMCP) for public procurements of drugs. 17 July 2024
Pharmaceutical
Lexicon Pharmaceuticals announced that the US Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista (sotagliflozin) 17 July 2024
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Ohtuvayre (ensifentrine). 17 July 2024
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