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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Pharmaceutical
The US Food and Drug Administration has issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. 19 April 2022
Biotechnology
Shionogi and fellow Japan-based NEC Corporation have executed a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. 19 April 2022
Pharmaceutical
Japanese companies Teijin Limited and JCR Pharmaceuticals have decided to terminate their co-development and Japan licensing agreement aimed at developing JTR-161, an allogeneic regenerative medical product containing dental pulp stem cells (DPCs) for the intended purpose of helping patients recover from acute cerebral infarctions (strokes). 19 April 2022
Biotechnology
Sino-American biotech firm BeiGene has announced that the China National Medical Products Administration (NMPA) has granted approval for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. 19 April 2022
Pharmaceutical
Trade body Medicines Australia congratulates Senator Anne Ruston on her proposed appointment as Minister for Health and Aging, if the country’s current Coalition is re-elected. 19 April 2022
Biotechnology
Among notable news last week, US biotech Seagen won a $41.8 million award through a US District Court ruling in its patent dispute with Japan’s Daiichi Sankyo over cancer drug Enhertu. USA-based Veru scored a big hit with Phase III data for its COVID-19 treatment candidate sabizabulin. On the M&A front, UK pharma major GlaxoSmithKline last Wednesday announced a $1.9 billion acquisition of Sierra Oncology, along with its myelofibrosis candidate momelotinib. Also announcing an M&A deal last Wednesday was specialty pharma company Halozyme Therapeutics, with a $960 million bid for Antares Pharma. 17 April 2022
Biotechnology
Danish biotech Genmab and the USA’s AbbVie have announced top-line results from the first cohort of the EPCORE NHL-1 Phase I/II, clinical trial evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody. 15 April 2022
Biotechnology
Not all that many things have gone well for US biotech bluebird bio in recent years, but the company had some good news this week in the shape of a draft report from the Institute for Clinical and Economic Review (ICER). 14 April 2022
Biotechnology
The US Food and Drug Administration’s (FDA) increasing approvals and Emergency Use Authorizations (EUAs) of COVID-19 vaccines and drugs, as well as cell and gene therapies, continue to provide ample manufacturing opportunities for contract manufacturing organizations (CMOs), says GlobalData. 14 April 2022
Biotechnology
USA-based Be Biopharma (“Be Bio”), a pioneer in the discovery and development of Engineered B Cell Medicines (BeCM) founded in October 2020, has announced the closing of a $130 million financing, bringing the total investment in the company to over $180 million. 14 April 2022
Biotechnology
In February, Dutch rare diseases biotech firm ProQR Therapeutics lost 74% of its market value in a single day after the failure of its pivotal Phase II/III Illuminate trial of sepofarsen. 14 April 2022
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended approval of Tepmetko (tepotinib) from Germany’s Merck KGaA for National Health Service (NHS) use. 14 April 2022
Biotechnology
The COVID-19 vaccine developed by French company Valneva has today been granted regulatory approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 14 April 2022
Pharmaceutical
Specialist UK-based drug discovery and development company ImmuPharma is trading 20% higher than earlier this week following the presentation of positive data from the Lupuzor/P140 pharmacokinetic (PK) study. 14 April 2022
Biotechnology
China-based biotech BeiGene has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 April 2022
Biotechnology
The European Commission (EC) has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. 14 April 2022
Pharmaceutical
On Wednesday, the US Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the USA into clinical trials – expanding on the agency’s previous guidance for industry to improve clinical trial diversity. 14 April 2022
Generics
Sandoz, the generic and biosimilar medicines business of Novartis, today announced the US launch of its generic combination eyedrop brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, an AB-rated generic equivalent to AbbVie’s Combigan, to lower eye pressure in patients with ocular hypertension (high eye pressure). 14 April 2022
Pharmaceutical
Shares in specialty pharmaceutical company Antares Pharma were up by nearly half at lunchtime on Wednesday with the news that the firm is to be acquired by Halozyme Therapeutics. 13 April 2022
Biotechnology
Acoramidis, an orally-administered small molecule transthyretin from US biotech BridgeBio Pharma that is currently being assessed in Phase II and Phase III trials, could compete with Pfizer’s Vyndaqel (tafamidis) in the transthyretin amyloidosis cardiomyopathy (ATTR-CM) and ATTR-polyneuropathy (ATTR-PN) market. 13 April 2022
All news
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
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
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