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
A jointly-issued notice from the US FDA and Federal Trade Commission (FTC) warns the marketers and distributors of 12 opioid cessation products regarding the illegal marketing of unapproved products. 24 January 2018
Biotechnology
USA-based Puma Biotechnology has said it is unlikely to receive the nod from the European medicines regulator for its breast cancer therapy Nerlynx when the agency votes on its application next month. 24 January 2018
Pharmaceutical
The European Medicines Agency is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health. 24 January 2018
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD), developed by Swedish drugmaker Camurus. 23 January 2018
Pharmaceutical
The European Medicines Agency has today published an overview of its key recommendations of 2017 regarding the authorization of new medicines and the safety monitoring of medicines, which shows that its tally of novel drug approvals was well below that achieved by its US peer. 23 January 2018
Pharmaceutical
German pharma major Bayer received good news from the UK on Tuesday in the shape of positive guidance from the National Institute for Health and Care Excellence (NICE) that underlines the value of Eylea (aflibercept solution for injection) as a treatment for people with wet age-related macular degeneration (AMD). 23 January 2018
Biosimilars
The Iranian biosimilar company CinnaGen has achieved a notable first for the middle east and north Africa (MENA) region. 23 January 2018
Pharmaceutical
A lobbying disclosure form filed by The Pharmaceutical Research and Manufacturers of America (PhRMA) reveals the leading industry trade body spent about a third more lobbying Washington last year, compared with 2016. 23 January 2018
Generics
An analyst at GlobalData affiliate PharmSource has poured cold water on the prospects for a newly-announced not-for-profit pharma company founded by hospital groups in the USA. 23 January 2018
Biotechnology
An extension to the conditional marketing authorization of Adcetris in the EU has sent Takeda’s share price up 2% in Tokyo today. 23 January 2018
Pharmaceutical
The USTR’s 2017 report on China’s compliance with World Trade Organization rules has found certain deficiencies with regards to intellectual property protection in the area of pharmaceuticals. 22 January 2018
Pharmaceutical
With the opioid abuse situation now spreading to many countries beyond the USA, Australia's medicines' regulator, the Therapeutic Goods Administration (TGA), has issued a discussion paper on the use and misuse of prescription strong opioids such as oxycodone and whether there is a need for specific regulatory responses. 22 January 2018
Generics
The US Department of Justice announced on Friday that a federal court in New Jersey has imposed a $5 million civil penalty and entered a consent decree of permanent injunction against the US subsidiary of India’s Dr Reddy’s Laboratories. 22 January 2018
Pharmaceutical
For years, China has been viewed with a mixture of excitement, optimism and suspicion by western pharmaceutical firms, with nervous investors wary of the relatively opaque political and economic environment in the country. 22 January 2018
Pharmaceutical
Regulatory decisions from the US Food and Drug Administration featured in the news last with, with a negative advisory panel vote on Aradigm’s antibiotic candidate Linhaliq and news of acceptance of a Biologicals License Application for a Humira (adalimumab) by Novartis subsidiary Sandoz. On the research front, Eiger Pharmaceutical’s pulmonary arterial hypertension drug ubenimex failed. There was strong speculation that Celgene was planning a takeover bid for CAR-T cell therapy specialist Juno Pharma. Also there was disappointment for Johnson & Johnson with the revocation of Johnson & Johnson’s Zytiga patent. 21 January 2018
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the new drug application for elobixibat for the treatment of chronic constipation in Japan, according to the drug’s developer, Albireo Pharma. 20 January 2018
Generics
In a move that expresses healthcare providers’ frustration with generics pricing and allegations of price gouging, a consortium of hospitals in the USA have hit on a radical solution - starting their own pharmaceuticals company. 19 January 2018
Biotechnology
AstraZeneca has won two new approvals in Japan, for Lynparza, the first PARP inhibitor to be approved in the country, and for asthma drug Fasenra. 19 January 2018
Biosimilars
The European Commission (EC) has granted marketing authorization for Mvasi (biosimilar bevacizumab). 19 January 2018
Generics
The cost of prescription drugs is at the forefront of discussions among patients, advocacy groups, prescribers, payers, pharmaceutical companies, and policy makers. One factor – though not the only factor – in driving the cost of prescription drugs is the availability of competing products. 19 January 2018
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 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
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