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
The Marketing Authorization Application (MAA) for nirsevimab has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the prevention of medically attended lower respiratory tract infections (LRTI) in all infants through their first respiratory syncytial virus (RSV) season. 18 February 2022
Biotechnology
Gilead Sciences has announced new one-year results from the ongoing Phase II/III CAPELLA trial evaluating lenacapavir, the investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. 17 February 2022
Biotechnology
Janssen Pharmaceutica, a subsidiary of US healthcare giant Johnson & Johnson, has entered into a collaboration with US biotech start-up Remix Therapeutics, for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix’s REMaster drug discovery platform. 17 February 2022
Biotechnology
China-based biotech BeiGene today announced that BeiGene’s BTK inhibitor Brukinsa (zanubrutinib) has received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 17 February 2022
Pharmaceutical
US pharma giant Merck & Co has announced new leadership for its Human Health business. 17 February 2022
Biosimilars
Even as US President Joe Biden called for the US Senate to approve his Build Back Better legislation to reduce the costs of prescription drugs provided through Medicare and cap out-of-pocket drug costs for seniors, including insulin at $35 per month, Indian drug manufacturers are expecting an even stronger focus on generics and biosimilars, reports The Pharma Letter’s India correspondent. 17 February 2022
Biotechnology
The UK Medicine and Healthcare Products Regulatory Agency has granted Promising Innovative Medicine (PIM) designation to Belgian drugmaker UCB’s zilucoplan for the treatment of adults with generalized myasthenia gravis (gMG). 17 February 2022
Biotechnology
US biotech Star Therapeutics has emerged from stealth mode with $100 million in financing and the ambition to be an innovation engine for rare disease therapies. 17 February 2022
Biotechnology
USA-based biotech Aimmune Therapeutics, which is now fully owned by Swiss foods giant Nestle (NESN: VX), today announced the publication of new clinical data from a pooled analysis of three controlled Phase III (PALISADE, RAMSES, ARTEMIS) and two open-label extension trials (ARC004, ARC011) of Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in the Journal of Allergy and Clinical Immunology (JACI). 17 February 2022
Generics
Sales of antiviral drugs in Russia are rapidly growing amid the ongoing pandemic in the country and the current high demand for them from local population, according to a recent report from DSM Group, the Russian pharma analytics company. 17 February 2022
Biotechnology
Coronavirus vaccine developer Moderna, which is pioneering messenger RNA (mRNA) therapeutics and vaccines, aims to expand its commercial network across six additional countries in Europe. 17 February 2022
Pharmaceutical
Russia may be faced with a shortage of Convulex (valproic acid) - one of the most popular drugs for the treatment of epilepsy – as its manufacturer, the Canadian firm Bausch Health, has stopped exports of the drug to the Russian market. 17 February 2022
Biotechnology
Shares in Austrian biopharma Hookipa closed up by more than half on Wednesday. 16 February 2022
Biotechnology
US biotech companies Sage Therapeutics and Biogen have announced that the CORAL study in people with major depressive disorder (MDD) met the trial objectives. 16 February 2022
Biotechnology
Third Harmonic Bio, a US clinical-stage company developing a first-in-class, highly selective, oral KIT inhibitor for treatment of severe allergy and inflammation, today launched from stealth, with the closing of a Series B financing that brings the total capital raised to date to $155 million. 16 February 2022
Pharmaceutical
California’s Cytokinetics has announced top-line results from the METEORIC-HF Phase III trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). 16 February 2022
Pharmaceutical
The European Commission (EC) has granted Marketing Authorization for Oxbryta (voxelotor), from Global Blood Therapeutics, for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). 16 February 2022
Biotechnology
Privately-held UK biotech Curve Therapeutics today announces a global research collaboration with US pharma giant Merck & Co, known as MSD outside the USA and Canada, to discover and validate modulators of up to five therapeutic targets using its Microcycle technology, initially for oncology and neurology indications. 16 February 2022
Pharmaceutical
The US Food and Drug Administration will have a new leader, after the Senate confirmed Robert Califf in a tight vote, 50 to 46, which exposed political divisions over a range of healthcare issues. 16 February 2022
Biotechnology
First-in-class lupus therapy Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for people with moderate to severe disease. 16 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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