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Pharmaceutical
Germany’s Federal Joint Committee (G-BA) has published the benefit assessment report for Japanese pharma major Eisai’s Lenvima (lenvatinib) for people with radioactive iodine refractory differentiated thyroid cancer. 6 October 2015
Pharmaceutical
US pharma company Bristol-Myers Squibb is to pay a $14.6 million fine to the US Securities and Exchange Commission over claims the company violated the Foreign Corrupt Practices Act (FCPA). 6 October 2015
Generics
The US Food and Drug Administration yesterday displayed a notice in the Federal Register announcing the availability of a guidance for industry, titled Acceptability of Draft Labeling to Support ANDA Approval. 6 October 2015
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today signed a Memorandum of Understanding (MoU) with its counterpart body in India. 5 October 2015
Pharmaceutical
Dako, an Agilent Technologies company, on Monday said the US Food and Drug Administration (FDA) approved a new test that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment. 5 October 2015
Biotechnology
Wales-based biotech company Cell Therapy will begin the application process for a conditional European marketing authorization for Heartcel. 5 October 2015
Generics
The US Food and Drug Administration has approved US generics drugmaker Impax Laboratories’ generic version of diabetes drug glyburides, marketed as Diabeta by France’s Sanofi. 5 October 2015
Generics
Family-owned German drugmaker Grünenthal Group says that its Tecnandina manufacturing plant in Ecuador has received certification from the Regulatory Authority of Brazil, ANVISA. 5 October 2015
Biotechnology
Amicus Therapeutics on Friday revealed that the US Food and Drug Administration is calling for additional data before approving its Fabry disease drug candidate migalastat. 3 October 2015
Pharmaceutical
The US Food and Drug Administration on Friday granted accelerated approval for pharma giant Merck & Co’s Keytruda (pembrolizumab) in a new indication. 3 October 2015
Biotechnology
Gilead Sciences said on Friday that US Food and Drug Administration has approved the use of its Letairis (ambrisentan) in combination with tadalafil for the treatment of pulmonary arterial hypertension. 3 October 2015
Biosimilars
The US Generic Pharmaceutical Association (GPhA) and its Biosimilars Council remain hopeful that discussions in Atlanta translate to Trans-Pacific Partnership (TPP) language that promotes access to treatments for patients all over the world. 3 October 2015
Biosimilars
The US Food and Drug Administration (FDA) has accepted the regulatory application by Swiss drug major Novartis’ generics unit Sandoz, for a biosimilar version of Amgen's Enbrel (etanercept). 2 October 2015
Pharmaceutical
The US Food and Drug Administration today approved US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. 1 October 2015
Pharmaceutical
The European Medicines Agency’s management board has nominated Guido Rasi as the executive director of the Agency. At an extraordinary session on October 1, the board selected Prof Rasi from a shortlist of candidates provided by the European Commission. 1 October 2015
article
Australia's medicines regulator, the Therapeutic Goods Administration, has today published an interim decision on a proposal to up-schedule codeine-containing medicines. 1 October 2015
Pharmaceutical
The new Medicines Australia Code of Conduct comes into effect from today, bringing in changes to transparency and self-regulation codes. 1 October 2015
Pharmaceutical
Health Canada is informing Canadians that the drug label for the multiple sclerosis (MS) drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML). 1 October 2015
Pharmaceutical
PTC Therapeutics on Wednesday said the European Medicines Agency has validated the submission for a variant of Translarna (ataluren) to treat nonsense mutation cystic fibrosis (nmCF). 30 September 2015
Pharmaceutical
Martindale Pharma on Wednesday said it has opened a scientific office in the Kingdom of Saudi Arabia (KSA) in line with its strategy to market its portfolio in potential high-growth markets saying this is a key step towards growing sales. 30 September 2015
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
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