Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Pharmaceutical
The long awaited European Medicines Agency relocation decision provides some certainty to the life sciences industry in an otherwise uncertain Brexit process, according to Helen Kimberley, a lawyer in Hogan Lovells' Commercial and Regulatory team, said. 21 November 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated ATTR amyloidosis (hATTR amyloidosis) with polyneuropathy. 21 November 2017
Pharmaceutical
The US Food and Drug Administration is investigating serious adverse events involving Limbrel (flavocoxid), a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis, by Primus Pharmaceuticals. 21 November 2017
Pharmaceutical
The Competition and Markets Authority, the UK’s primary competition and consumer authority, has provisionally found that Concordia abused a dominant position to overcharge the country’s National Health Service for an essential thyroid drug. 21 November 2017
Pharmaceutical
The European Commission has given its backing to broaden the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications. 21 November 2017
Pharmaceutical
European heads of state have chosen Amsterdam as the new home for the European Medicines Agency post-Brexit, simultaneously ending months of speculation and the hopes of 18 other nations bidding to host the prestigious organization. 21 November 2017
Biotechnology
The International Society for Cellular Therapy has welcomed the US FDA’s newly-released comprehensive Regenerative Medicine Policy Framework. 20 November 2017
Pharmaceutical
The US Food and Drug Administration has granted pediatric exclusivity for Adcirca (tadalafil) tablets through May 21, 2018, based on study results submitted by Eli Lilly in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy. 20 November 2017
Biosimilars
Samsung Bioepis has had its marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), approved by the European Commission (EC). 20 November 2017
Pharmaceutical
Last week’s most interesting news included a mega licensing deal by Germany’s Bayer, which acquired rights to Loxo Oncology’s cancer candidate larotrectinib for up to $1.55 billion. There was also a great deal of news on the regulatory front, with Heron Therapeutics gaining US Food and Drug Administration approval for its CINV drug Cinvanti. Celgene and bluebird bio were granted Breakthrough and PRIME designation for their multiple myeloma candidate bb2121, and FDA approval came through for AstraZeneca’s asthma drug Fasenra and Ultragenyx’ Sly syndrome treatment Mepsevii. 19 November 2017
Pharmaceutical
Over three decades ago, the United States Congress passed the Orphan Drug Act in 1983. The Act focused on drug development for rare diseases, defined as affecting fewer than 200,000 people. Before Congress enacted this legislation, companies had very little incentive to invest money in the development of these drugs, writes Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. 18 November 2017
Biotechnology
A CAR-T therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) and PRIME eligibility by the European Medicines Agency (EMA). 17 November 2017
Biotechnology
The US Food and Drug Administration has approved Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). 17 November 2017
Biotechnology
The US Food and Drug Administration has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. 16 November 2017
Biotechnology
The US Food and Drug Administration yesterday approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. 16 November 2017
Biotechnology
As a result of price deals with the manufacturers of breast cancer drugs palbociclib and ribociclib, they have received a green light for routine National Health Service (NHS) funding in England, says the National Institute for Health and Care Excellence. 16 November 2017
Biotechnology
Russia’s largest biotech firm Biocad has sent a package of documents for re-registration of the price of a number of vital medicines down by 50% to 91%. 15 November 2017
Pharmaceutical
AstraZeneca announced three separate approvals of products in asthma and cancer on Tuesday and closed 1.8% up in the stock market. 15 November 2017
Pharmaceutical
If Health Canada achieves its goal of lowering the maximum prices for drugs, the health of Canadians could suffer, shows a Viewpoint published today by the Montreal Economic Institute (MEI), an independent, non-partisan, not-for-profit research and educational organization. 15 November 2017
Biotechnology
New Zealand’s Pharmaceutical Management Agency PHARMAC said today that it proposes to fund cetuximab (Erbitux) from February 1, 2018 for the treatment of patients with locally advanced, non-metastatic, squamous cell cancer of the head and neck subject to certain clinical criteria being met. 15 November 2017
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
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