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
AstraZeneca says that the National Institute of Health and Care Excellence (NICE) has today published a Technology Appraisal Guidance (TAG) recommending Daxas (roflumilast) for use within NHS England as an add-on option to treat adults with severe chronic obstructive pulmonary disease (COPD) who continue to experience exacerbations despite triple inhaled therapy. 26 July 2017
Pharmaceutical
China has released a new list of 36 drugs, including 31 chemicals and biologics and five traditional Chinese medicines, covered by China’s national Medicare reimbursement scheme, reports The Pharma Letter’s local correspondent Wang Fangquing. 25 July 2017
Biotechnology
The Biotechnology Innovation Organization (BIO), the trade group representing biotech companies in the USA, has set out its opposition to a drug cost plan released by Congressional Democrats. 25 July 2017
Pharmaceutical
The European Commission has granted the marketing authorization for Trimbow (beclomethasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) for COPD. 25 July 2017
Biosimilars
In a quarterly Special Report piece, Andrew Williams, patent law expert, partner at Chicago-based IP law firm McDonnell Boehnen Hulbert & Berghoff and chair of its Patent Trial and Appeal Board (PTAB) Trials Practice Group, writes about a crucial case affecting the marketing of biosimilars in the USA. 25 July 2017
Pharmaceutical
Following a submission in its native Japan, pharma major Eisai has submitted applications for its in-house discovered and developed anticancer agent lenvatinib mesylate for the treatment of hepatocellular carcinoma (HCC) in both the USA and Europe. 25 July 2017
Biotechnology
Eli Lilly and Incyte Corp have announced a further delay in US approval of their rheumatoid arthritis drug candidate baricitinib. 25 July 2017
Generics
Bangladesh's Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its generic version of Auxilium Pharmaceuticals' Robaxin (methocarbamol) tablets. 25 July 2017
Biotechnology
Stem cells are expected to dramatically improve the ability of drug companies to screen new drugs for side effects much earlier in the development process. Given that this is expected to significantly lower costs and shorten the time it takes to develop a new drug, India is looking to set forth new guidelines for stem cell research, reports The Pharma Letter’s India correspondent. 25 July 2017
Pharmaceutical
AbbVie has been ordered to pay $150 million to a patient who claimed that the US drugmaker hid the risks of its AndroGel testosterone booster in aggressive advertising campaigns. 25 July 2017
Biosimilars
South Korean drug developer Samsung Bioepis, a joint venture between Korean conglomerate Samsung and US biotech Biogen, has announced the launch of its first biosimilar in the USA. 24 July 2017
Biotechnology
The US Food and Drug Administration has expanded the indication for blockbuster cancer drug Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. 24 July 2017
Biotechnology
US cancer-selective gene therapy company Tocagen has announced that its Toca 511 (vocimagene amiretrorepvec) treatment of patients with high grade glioma (HGG), a type of brain tumor, has received PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA). 24 July 2017
Pharmaceutical
The Social Market Foundation, in conjunction with Swiss pharma giant Novartis, have today released a new report on designing a new drug system to save the UK’s National Health Service (NHS) money while also getting medicines to patients faster. 24 July 2017
Pharmaceutical
All parts of the pharmaceutical industry in Hungary have come together to prevent falsified medicinal products from getting into the supply chain. 24 July 2017
Biotechnology
Chugai Pharmaceutical says it has filed a new drug application for its anti-coagulation factor IXa/X humanized bispecific monoclonal antibody emicizumab to the Ministry of Health, Labor and Welfare (MHLW). 24 July 2017
Biotechnology
The US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. 24 July 2017
Biotechnology
The US Food and Drug Administration has granted a Rare Pediatric Disease designation to OTL-101, for the treatment of adenosine deaminase severe combined immunodeficiency, commonly known as ADA-SCID or “bubble baby” disease. 24 July 2017
Pharmaceutical
The US Food and Drug Administration’s actions were behind some of the leading pharma and biotech news last week. This included marketing approval for Johnson & Johnson’s plaque psoriasis drug candidate Tremfya and Gilead Sciences latest hepatitis C drug Vosevi, as well as a setback for Amgen’s osteoporosis treatment Evenity. Added to this, was the welcome news that Novartis and Amgen’s migraine drug erenumab New Drug Application has been accepted by the agency. 23 July 2017
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval at its July meeting, and rejected two. 22 July 2017
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Biotechnology
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
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
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