Latest Pharma and Biotech News
Biotechnology
28 November 2024 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.
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Biotechnology
There are fears that US biotech company Moderna could undermine the World Health Organization’s (WHO) efforts to manufacture more mRNA vaccines in Africa, after it emerged the company has filed several patents related to its coronavirus jab. 14 February 2022
Pharmaceutical
Russian drugmaker R-Pharm Group, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and UK pharma major AstraZeneca have announced interim results of Phase II clinical trials to evaluate the safety and immunogenicity of the combined use of AstraZeneca's vaccine, now trade-named Vaxzevria, and the first component of the Sputnik V coronavirus vaccine (Sputnik Lite). 14 February 2022
Pharmaceutical
Shares of specialty drugmaker BioDelivery Sciences International shot up 52% to $3.64 in pre-market trading today, after it agreed to be acquired by fellow USA-based Collegium Pharmaceuticals. 14 February 2022
Pharmaceutical
The UK business of New York-based pharma giant Pfizer has appointed Susan Rienow as managing director. 14 February 2022
Pharmaceutical
UK health technology assessor the National Institute for Health cand Care Excellence (NICE) last week issued draft guidance recommending Wegovy (semaglutide) for adults with at least one weight-related condition and a body mass index (BMI) of at least 35 kg/m2, and exceptionally, to people with a BMI of 30.0 kg/m2 to 34.9 kg/m2. 14 February 2022
Biotechnology
The US Food and Drug Administration (FDA) has blocked attempts to halt trials of Cassava Sciences’ experimental Alzheimer’s drug simufilam. 14 February 2022
Pharmaceutical
Shares of Bavarian Nordic were down 3.7% at 164.55 Danish kroner by late morning today, despite announcing that the US Food and Drug Administration has granted Breakthrough Therapy designation for the Danish company's vaccine candidate, MVA-BN RSV, for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years or older. 14 February 2022
Biotechnology
An Expert View providing best practices on developing a sound commercial strategy, building out secure logistics platforms, and creating a connected ecosystem through technology from Andrea Zobel, senior director of Personalized Supply Chain at World Courier (a part of AmerisourceBergen), Melissa Lattanzi, senior director of Channel Strategy at AmerisourceBergen, and Jason Ramseth, chief product officer at TrakCel. 14 February 2022
Biotechnology
In the USA, research from the US Centers for Disease Control and Prevention (CDC) has shown that COVID-19 vaccine boosters “continue to be highly effective against severe disease over time.” 14 February 2022
Pharmaceutical
Pharma trade group Medicines Australia notes the introduction of patent box legislation, Treasury Laws Amendment (Tax Concession for Australian Medical Innovations) Bill 2022, in the Australian Parliament yesterday. 14 February 2022
Generics
Zydus, a part of Cadila Healthcare, today announced that its US subsidiary has received final approval from the US Food and Drug Administration to market roflumilast tablets in the strength of 500mcg and a tentative approval for roflumilast tablets. 14 February 2022
Pharmaceutical
Research news last week saw US cancer focussed firm Karyopharm Therapeutics release a bullish review of new Phase III data on its endometrial cancer candidate selinexor. Financial results were also in focus. Pfizer, the world’s largest prescription medicines maker last Tuesday reported record fourth quarter 2021 figures, boosted by its hugely successful covid vaccine Comirnaty but issued conservative longer-term guidance. UK-based AstraZeneca also announced financials which pleased markets but also raised some questions regarding its vaccine rollout. On the regulatory front, a US Food and Drug Administration advisory committee voted against approval of Eli Lilly and Innovent’s lung cancer candidate sintilimab, citing the grounds of a China-based clinical trial backing the application as not appropriate. 13 February 2022
Biotechnology
The US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the Omicron variant. 12 February 2022
Biotechnology
Cumulative five-year results from two Phase III studies (Study 1489 and Study 1490) of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) were announced on Friday. 12 February 2022
Biotechnology
Dutch rare diseases biotech firm ProQR Therapeutics saw its shares plummet more than 74% to $1.45 today, as it announced that its pivotal Phase II/III Illuminate trial of sepofarsen for the treatment of CEP290-mediated Leber congenital amaurosis 10 (LCA10) did not meet its primary endpoint of best corrected visual acuity (BCVA) at Month 12. 11 February 2022
Biotechnology
US biotech Biogen has put further pressure on the Centers for Medicare & Medicaid Services (CMS) over guidance that it issued last month in relation to Aduhelm (aducanumab). 11 February 2022
Pharmaceutical
Ipsen has reported annual revenues of 2.87 billion euros ($3.3 billion), falling just short of the FT consensus forecast of 2.9 billion euros. 11 February 2022
Biotechnology
Canada-based companies Imagia Cybernetics, AI-healthcare company, and Canexia Health have announced their planned merger, which is expected to close at the end of February, subject to shareholder approval. 11 February 2022
Pharmaceutical
Members of the US House of Representatives have written a letter to Secretary of Health and Human Services (HHS) Xavier Becerra urging him to follow through with the Biden administration’s commitment to lowering exorbitant prescription drug costs. 11 February 2022
Biotechnology
Already marketed and pipeline candidate Janus kinase (JAK) inhibitors have recently suffered setbacks in the USA, since the Food and Drug Administration found safety issues with the class of drugs and ordered Back Box label warnings. 11 February 2022
All news
Biotechnology
Belgium’s largest drugmaker UCB on Friday announced the successful closing of the sale, divestment and license of its mature neurology and allergy portfolio in China to CBC Group, Asia’s largest healthcare-focused asset management group, and Mubadala Investment Company for an enterprise value of $680 million, first announced earlier this year. 30 November 2024
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
Minghui Pharmaceutical has reported encouraging results from a Phase III trial of MH004 (tofacitinib etocomil) in mild to moderate atopic dermatitis (AD). 29 November 2024
Biotechnology
Allink Biotherapeutics, a Chinese start-up focused on bispecific antibody and antibody-drug conjugates (ADC), has raised $42 million in a financing round led by Lanchi Ventures. 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
The currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. 29 November 2024
Pharmaceutical
Taiwan-based Formosa Pharmaceuticals (6838: TW) revealed that it has entered into an exclusive licensing agreement with Medvisis Switzerland, in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. 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
Pharmaceutical
German family-owned pain focused drugmaker Grünenthal has announced the pricing of 500 million-euro ($527.5 million) aggregate principal amount of 4.625% senior secured notes due 2031. 29 November 2024
Biotechnology
Zug-based Galderma has published positive results from the Phase III OLYMPIA 1 trial in JAMA Dermatology, as the company’s newly-minted shares change hands in record volumes. 29 November 2024
Biotechnology
Indian drugmaker Dr Reddy’s Laboratories has launched its toripalimab in the domestic market, sending the firm’s share up 2%. Toripalimab is a New Biological Entity (NBE), the company noted. 29 November 2024
Pharmaceutical
Germany’s Evotec has said its chief operating officer Craig Johnstone will leave the business at the end of the year. 29 November 2024
Biotechnology
French pharma major Sanofi has added a new plant in Singapore to make vaccines and other medicines, as the company seeks to bolster preparedness for emergencies, including potential pandemics, according to Bloomberg and other media reports. 29 November 2024
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
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
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