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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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Biotechnology
The US Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. 26 February 2021
Biotechnology
US biotech Pandion Therapeutics’ shares rocketed 133% to $59.63 in morning trading, after it was revealed that it has agreed to be acquired by US pharma giant Merck & Co. 25 February 2021
Biotechnology
US biotech Regeneron Pharmaceuticals today announced changes to the Phase III trial assessing investigational REGEN-COV (casirivimab with imdevimab) in non-hospitalized patients (outpatients) with COVID-19, following recommendations from the Independent Data Monitoring Committee (IDMC). 25 February 2021
Biotechnology
Chinese biotech Clover Biopharmaceutical has raised nearly a quarter of a billion dollars in a series C financing round, bringing the total amount raised in the last 12 months to $400 million. 25 February 2021
Biotechnology
The US Food and Drug Administration (FDA) has placed bluebird bio’s Phase I/II and Phase III studies of LentiGlobin gene therapy for sickle cell disease (SCD) on a clinical hold. 25 February 2021
Biotechnology
Shares of US biotech Moderna were up more than 4% at $151.10, after it announced on Wednesday that it has completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa. 25 February 2021
Biotechnology
The Austrian Center of Industrial Biotechnology (acib) has published research in Scientific Reports describing less common coronavirus mutations which could be of significance for researchers. 24 February 2021
Biotechnology
US biotech Beam Therapeutics saw its shares fall 12.6% to $96.48 yesterday, after it announced it has completed the acquisition of Guide Therapeutics (GuideTx). 24 February 2021
Biotechnology
US biotech Scynexis has partnered with Amplity Health in connection with the anticipated US launch of Brexafemme (ibrexafungerp). 24 February 2021
Biotechnology
US clinical-stage biopharma firm Day One Biopharmaceuticals has entered into a global licensing agreement with Germany’s Merck KGaA, for an exclusive license to develop and commercialize pimasertib as well as a second compound, MSC2015103B. 23 February 2021
Biotechnology
Hopes that BrainStorm Cell Therapeutics could deliver a new option in amyotrophic lateral sclerosis (ALS) have been dealt a blow by negative feedback from the US regulator. 23 February 2021
Biotechnology
A third US approval for checkpoint blocker Libtayo (cemiplimab-rwlc) has been won by Regeneron Pharmaceuticals and its partner, French pharma major Sanofi. 23 February 2021
Biotechnology
The UK subsidiary of US biotech firm Seagen today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in Great Britain for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. 22 February 2021
Biotechnology
The Parkinson’s disease (PD) pipeline has been hit significantly with a string of failures among its most anticipated mid-stage pipeline candidates. 22 February 2021
Biotechnology
Sunday February 28 is Rare Disease Day – a time to review the current orphan drug landscape and the opportunities and challenges presented to the pharmaceutical industry. 22 February 2021
Biotechnology
A study in Israel indicates that a single dose of BioNTech and Pfizer’s coronavirus vaccine is 85% effective. 22 February 2021
Biotechnology
Anglo-Swedish pharma major AstraZeneca has announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the USA for previously-treated adults with locally advanced or metastatic bladder cancer. 22 February 2021
Biotechnology
Following an earlier setback in their collaboration on an adjuvanted recombinant protein-based COVID-19 vaccine program last December, France’s Sanofi and the UK’s GlaxoSmithKline are moving forward again. 22 February 2021
Biotechnology
Shares of US clinical-stage biotech Vaccinex leapt as much as 233% to an intraday high of $9.56 on Friday, after it disclosed the signing of multi-project deals with two undisclosed prominent pharmaceutical companies. 20 February 2021
Biotechnology
Clinical-stage US biotech Provention Bio has entered into a strategic collaboration with a subsidiary of China’s Huadong Medicine to develop and commercialize PRV-3279, a DART (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B, in Greater China (mainland China, Hong Kong, Macau and Taiwan). 20 February 2021
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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
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
Biotechnology
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Biotechnology
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
Biotechnology
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Biotechnology
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
Biotechnology
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Biotechnology
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 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
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 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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