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Pharmaceutical
27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
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Pharmaceutical
UK-based Verona Pharma pleased investors today, as it announced positive results from its Phase III ENHANCE-2 trial of ensifentrine for the treatment of chronic obstructive pulmonary disease (COPD), news of which sent the firm’s shares up more than 100% to $13.93 in pre-market trading. 9 August 2022
Biotechnology
Chinese biotech BeiGene has announced that the global Phase III RATIONALE 301 trial with tislelizumab met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). 9 August 2022
Biotechnology
US clinical-stage biotech Mersana Therapeutics saw its shares trading up 14.1% at $5.99 pre-market this morning, after it announced a global collaboration that provides UK pharma major GSK with an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2. 9 August 2022
Biotechnology
French drugmaker Sanofi has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent data monitoring committee (iDMC), resulting in an almost 2% drop in its share price. 9 August 2022
Biotechnology
Danish biotech Genmab says it is improving its 2022 financial guidance that was published on May 11 this year. 9 August 2022
Generics
Japanese drug major Chugai Pharmaceutical announced that, along with majority owner Roche and its biotech subsidiary Genentech (collectively “the companies”) have entered into a settlement agreement with Fresenius Kabi USA, on August 5, 2022 relating to the patent lawsuit filed by the companies on March 19, 2020. 9 August 2022
Biotechnology
The outlook for a much-anticipated innovative treatment for Huntington’s disease has been muddied by a surprise serious side effect in a Phase I/II trial. 9 August 2022
Biotechnology
German biotech company BioNTech was trading more than 10% lower on Monday afternoon in New York after announcing its latest financial results. 8 August 2022
Pharmaceutical
The outbreak of coronavirus disease (COVID-19) has brought the issue of localization to the forefront, which necessitated the need for localization of pharmaceutical manufacturing to achieve self-sufficiency and self-reliance, writes The Pharma Letter's local correspondent. 8 August 2022
Biotechnology
Following positive results in a Phase III study of fruquintinib, Hutchmed's shares were on the way up on Monday. 8 August 2022
Biotechnology
Preliminary results from the Savannah Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate of almost 50% in patients. 8 August 2022
Biotechnology
US clinical-stage biotech firm Karuna Therapeutics saw its shares leap more than 40% to $197.50 pre-market today, as it announced positive top-line results from its Phase III EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of KarXT (xanomeline-trospium), an oral investigational M1/M4-preferring muscarinic agonist, in adults with schizophrenia. 8 August 2022
Pharmaceutical
Big M&A rumors continue to swirl round the pharma world this summer, with talk of a Pfizer bid for Global Blood Therapeutics in the offing. 8 August 2022
Pharmaceutical
US President Joe Biden looks set to secure a major legislative win that would affect drug pricing in the country, as the Inflation Reduction Act narrowly won Senate approval on Sunday. 8 August 2022
Biotechnology
Cash-rich pharma giant Pfizer is continuing its spending spree, with the $5.4 billion acquisition of rare blood disease specialist Global Blood Therapeutics. 8 August 2022
Pharmaceutical
Spanish drugmaker PharmaMar has announced that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 8 August 2022
Pharmaceutical
Myovant Sciences and Pfizer have received US Food and Drug Administration (FDA) approval for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months as per the attachment. 8 August 2022
Biotechnology
USA-based biotech EQRx on Sunday announced a late-breaking oral presentation of updated data from the Phase III GEMSTONE-301 trial of sugemalimab in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place August 6 through August 9, 2022. 8 August 2022
Biotechnology
Sino-American biotech BeiGene saw its shares close up more than 12% at 112.05 renminbi on Friday, after it reported financial results for the second quarter of 2022, recent business highlights, and anticipated upcoming milestones. 8 August 2022
Biotechnology
Japanese drugmaker Maruho has launched the anti-interleukin (IL)-31 receptor A humanized monoclonal antibody Mitchga (nemolizumab [genetical recombination]) subcutaneous Injection 60mg syringes for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective). 8 August 2022
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Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 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
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 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
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 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
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 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
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 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
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 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
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