Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
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Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Pharmaceutical
Following the news that Donald Trump is the winner of the 2024 US Presidential Election, Morningstar Equity analyst Julie Utterback has published a new note about the impact of this on the managed-care industry. 7 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
UK pharma major AstraZeneca, which has invested heavily in China, hosted a sell-side analyst call on Wednesday (November 6) to discuss the recent media reports about ongoing investigations in China. 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Pharmaceutical
Some of the UK’s leading academics and industry professionals have welcomed Chancellor Rachel Reeves’ £520 million ($669 million) pledge to develop the country’s medicine manufacturing capabilities. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
The Danish government is rolling out the red carpet and welcomes several pharmaceutical companies. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Pharmaceutical
A meeting was held last week between the president of the Greek government’s Negotiation Committee, Nadia Gogozotou, and representatives of SFEE, the Hellenic Association of Pharmaceutical Companies. 20 March 2023
Biotechnology
A new analysis based on data from the Phase III CLARITY AD trial of Leqembi (lecanemab) has been published in Neurology and Therapy. 20 March 2023
Pharmaceutical
The trade group European Federation of Pharmaceutical Industries and Associations (EFPIA) has slammed recent new regulations, saying they delay medical research. 20 March 2023
Biotechnology
Biopharma M&A news last week included the largest deal in around four years, with US pharma giant Pfizer last Monday confirming it is to acquire biotech firm Seagen, but with the price of $43 billion much higher than the $30 billion rumored prior to the formal announcement. Also, French pharma major Sanofi announced a $2.9 billion takeover bid for USA-based Provention Bio, along with its diabetes drug Tzield. Last week also saw the US Centers for Medicare and Medicaid Services (CMS) announce more details of its plan for savings on Medicare Part B drugs. Additionally, the US Food and Drug Administration made a surprise U-turn, calling for an advisory committee meeting ahead of its anticipated regulatory decision for Sarepta Therapeutics' Duchenne muscular dystrophy (DMD) candidate SRP-9001. 19 March 2023
Pharmaceutical
The Singapore Health Sciences Authority (HSA) has approved its 20-valent pneumococcal conjugate vaccine (PCV20) that protects against invasive pneumococcal disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. 18 March 2023
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) is continuing to play a lead role in debate over drug prices in the USA. 17 March 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. 17 March 2023
Pharmaceutical
A US Food and Drug Administration (FDA) advisory committee has voted by 16 to one that data support the safety and effectiveness of Paxlovid (nirmatrelvir/ritonavir) for mild-to-moderate COVID-19 in adults at high risk for progression to severe illness. 17 March 2023
Pharmaceutical
A new approval for Swiss pharma giant Novartis will open up a broader use for Tafinlar (dabrafenib) plus Mekinist (trametinib) in oncology. 17 March 2023
Biotechnology
US precision genetic medicine for rare diseases developer Sarepta Therapeutics yesterday revealed that, at its late cycle meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA), the US Food and Drug Administration’s Office of Therapeutics (OTP) has determined that an advisory committee meeting will be held for the drug candidate in advance of the May 29, 2023 regulatory action date. 17 March 2023
Pharmaceutical
Following announcements in in the last few days, first by Eli Lilly and then by Novo Nordisk, French pharma major Sanofi revealed that it too would slash the US price of its insulin products. 17 March 2023
Pharmaceutical
Implementation is moving forward on President Joe Biden’s Inflation Reduction Act (IRA) policy that allows Medicare to negotiate lower prescription drug prices. 16 March 2023
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) is recommending the use of Zolgensma (onasemnogene abeparvovec) as an option in babies with presymptomatic 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene, said Swiss Pharma giant Novartis. 16 March 2023
Pharmaceutical
In a highly unusual move, the UK pharmaceutical industry’s trade body has suspended the membership of Danish diabetes giant Novo Nordisk. 16 March 2023
Pharmaceutical
The impact of US President Joe Biden's Inflation Reduction Act is beginning to be felt, as Danish diabetes giant Novo Nordisk announced plans to slash the cost of insulin. 15 March 2023
Biotechnology
The US Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), has announced 27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 to June 30. 15 March 2023
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has unleashed a broadside against decision-makers in Brussels. 15 March 2023
Biotechnology
British biopharmaceutical companies have welcomed an announcement from the UK’s Chancellor, Jeremy Hunt, of a new enhanced R&D tax relief rate for certain innovators. 15 March 2023
Pharmaceutical
An Expert View from the global consulting firm CRA's Steve Kelly, Mike Hodder and Owen Jones. 15 March 2023
Biotechnology
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals yesterday announced that its Qinlock (ripretinib) has been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line gastrointestinal stromal tumor (GIST) patients intolerant to sunitinib. 15 March 2023
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