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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 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 BeOne Medicines, formerly 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
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
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
Pharmaceutical
Some of the biggest players in the pharmaceutical industry have called for an overhaul of the way the UK’s National Institute for Health and Care Excellence (NICE) assesses cancer drugs. 13 February 2016
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalized a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimize the risk of diabetic ketoacidosis. 12 February 2016
Biosimilars
As advocates for policies that support patient access to biosimilars, the Biosimilars Council, a division of the US trade group the Generic Pharmaceutical Association (GPhA), has said it is disappointed in the World Health Organization’s final proposal on the Biological Qualifier (BQ), which could be a barrier to competition from these new versions of critical medicines. 12 February 2016
Pharmaceutical
Japan’s Shionogi has submitted a New Drug Application for the manufacturing and marketing in Japan of S-877503 (guanfacine hydrochloride prolonged release tablets; marketed in the USA as Intuniv), for the treatment of attention-deficit hyperactivity disorder (ADHD) in children. 12 February 2016
Pharmaceutical
A significant part of vital drugs may disappear from the Russian market during the next several months as, due to Russian bureaucracy, many foreign drugmakers will be forced to suspend further sales of their drugs in the Russian market. 11 February 2016
Biosimilars
Global biosimilars leader Sandoz has had its Marketing Authorization Application for its biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim) accepted by the European Medicines Agency. 11 February 2016
Biosimilars
US biotech firm Momenta Pharmaceuticals revealed today that the Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the global collaboration agreement executed last month with Netherlands-incorporated Mylan. 10 February 2016
Biosimilars
The US Food and Drug Administration Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech's Remicade (infliximab), by a vote of 21-3. 10 February 2016
Pharmaceutical
The US Food and Drug Administration is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year 2017 budget – an 8% increase over the enacted budget for FY 2016. 10 February 2016
Pharmaceutical
Safety for medicines will be further reinforced with the introduction of new obligatory features like a unique identifier and an anti-tampering device, according to an announcement this morning from the European Commission. 9 February 2016
Pharmaceutical
A new ovarian cancer drug has been submitted for marketing authorization to the European Medicines Agency (EMA) by Swedish firm Oasmia Pharmaceutical. 9 February 2016
Biotechnology
Shares of US RNA-based drug developer Sarepta Therapeutics were down 12.2.% at $10.74 in late-morning trading, after the company revealed it is facing yet another delay in a decision from the US Food and Drug Administration as to whether its Duchenne muscular dystrophy (DMD) drug candidate eteplirsen would gain marketing approval. 8 February 2016
Pharmaceutical
The European Medicines Agency has established a task force of European experts with specialized knowledge in vaccines, infectious diseases and other relevant expertise to contribute to the global response to the threat of the Zika virus infection. 8 February 2016
Pharmaceutical
Britain’s National Institute for Health and Care Excellence (NICE) has published draft guidance against prescribing Sanofi/Regeneron's Praluent (alirocumab) for people with high cholesterol. 8 February 2016
Pharmaceutical
Delegates at Chinese pharma symposium agree that medical representatives play an important role in connecting medical personnel with pharmaceutical companies. 8 February 2016
Biosimilars
On February 9, 2016, the Food and Drug Administration’s Arthritis Advisory Committee is scheduled to hold an advisory hearing on an application for South Korean firm Celltrion’s CT-P13, a biosimilar version of infliximab. 6 February 2016
Biotechnology
US biotech firm Immunomedics (Nasdaq: IMMU) saw its shares leap 29% to $2.34 in heavy trading volume on Friday morning, after the company's investigational breast cancer drug received Breakthrough Therapy designation from the US Food and Drug Administration. 5 February 2016
Pharmaceutical
The Cancer Drug Fund, a resource set up to improve drug access for patients, lacks effective management, UK’s Public Accounts Committee (PAC) has reported. 5 February 2016
Pharmaceutical
In response to the opioid abuse epidemic in the USA, yesterday Robert Califf, the US Food and Drug Administration’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, called for a far-reaching action plan to reassess the agency’s approach to opioid medications. 5 February 2016
Pharmaceutical
A new analysis from the Personalized Medicine Coalition (PMC) documents an upward trend in the number of personalized medicine approvals at the US Food and Drug Administration, with personalized medicines accounting for more than one in four novel new drugs (NNDs) approved in 2015. 5 February 2016
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