Last week saw the announcement of two large licensing agreements. First, Gilead Sciences’ subsidiary Kite entered into a deal with BioNTech, whereby the German biotech, mostly in the news due to its COVID-19 vaccine developed with Pfizer, has acquired an R&D platform and clinical manufacturing facility in Maryland. The second deal was US pharma giant Pfizer signing an agreement with Arvinas for rights to the latter’s breast cancer candidate, ARV-471, that could cost it more than $2 billion. On the regulatory front, US biotech bluebird bio gained regulatory approval from the European Commission for its gene therapy Skysona. Also, Albireo received approval from both the US Food and Drug Administration and the European Medicines for its rare liver disease drug Bylvay. 25 July 2021
The US Food and Drug Administration yesterday approved Bydureon and Bydureon BCie (exenatide extended-release) injection to be used in addition to diet and exercise to improve glycemic control (blood sugar levels) in pediatric patients 10 years or older with type 2 diabetes. 23 July 2021
The US Food and Drug Administration approved Keytruda (pembrolizumab) from Merck & Co in combination with Japanese drugmaker Eisai’s Lenvima (lenvatinib) for patients with advanced endometrial carcinoma' 22 July 2021
US clinical-stage biotech Magenta Therapeutics’ shares closed down more than 9% at $8.07 on Wednesday, after the company revealed it has received a clinical hold letter from the US Food and Drug Administration related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase I/II clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). 22 July 2021
Venclexta (venetoclax), in combination with azacytidine, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International prognostic scoring system (IPSS-R). 21 July 2021
The US Food & Drug Administration approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC), developed by Boston, USA-based Albireo Pharma. 21 July 2021
The US Food and Drug Administration has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients six years of age and older and weighing at least 20 kg. 21 July 2021
Shares of California, USA-based cardiorenal specialist Ardelyx plunged more than 70% to $2.28 in after-hours trading on Monday, as the company revealed the US regulator is not ready to approve its tenapanor for dialysis patients. 20 July 2021
The US Food and Drug Administration (FDA) has granted Priority Review designation for the Biologics License Application (BLA) for the COVID-19 vaccine from Pfizer and BioNTech. 19 July 2021
The US Food and Drug Administration (FDA) approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. 19 July 2021
Licensing agreements featured heavily in last week’s news, starting with US biotech Biogen entering into an agreement that could cost it $1 billion to get rights to a BTK inhibitor – orelabrutinib for multiple sclerosis – from China’s InnoCare Pharma. Denmark’s Novo Nordisk in-licensed rights to Prothena’s ATTR amyloidosis program, and PRX004, in a deal worth up to $1.2 billion. Also, Ionis Pharmaceuticals last Tuesday exercised an option on fellow USA-based Bicycle Therapeutics’ oligonucleotide targeting the transferrin receptor 1. On the M&A front, Eli Lilly revealed on Wednesday it was acquiring privately-held US company Protomer Technologies for what could be a $1 billion transaction, getting rights to its glucose-sensing insulin project. Additionally, the US Food and Drug Administration took issue with Amgen’s promotion of its cancer drug Neulasta, which the agency said could undermine confidence in biosimilars. 18 July 2021
Shares of USA-based Kadmon Holdings shot up more than 20% to $4.28 on Friday, after the company revealed its pharma unit had received its first regulatory approval, for Rezurock (belumosudil). 17 July 2021
The US Food and Drug Administration on Friday approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. 17 July 2021
USA-based FibroGen's shares have dropped by more than a third after a scientific panel of the US Food and Drug Administration voted against approval of roxadustat. 16 July 2021
Looking to overturn a regulatory rebuff, New Jersey, USA’s Merck & Co has announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase III study KEYNOTE-522. 16 July 2021
The Food and Drug Administration (FDA) has issued an untitled letter to US biotech giant Amgen for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. 15 July 2021
The US Food and Drug Administration has lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the USA, Poland largest biotech Ryvu Therapeutics (WSE: RVU) announced today. 14 July 2021
The US Food and Drug Administration (FDA) has announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson COVID-19 jab. 14 July 2021
The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. 13 July 2021
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
Spanish epigenetics firm Oryzon Genomics has announced the receipt of the official meeting minutes from a recent End-of-Phase II meeting for vafidemstat in borderline personality disorder (BPD) with the US Food and Drug Administration (FDA). 2 October 2024
The US Food and Drug Administration (FDA) granted traditional approval for US pharma major Eli Lilly’s Retevmo (selpercatinib) for adult and pediatric patients two years and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation. 30 September 2024
Significant regulatory news last week included the US Food and Drug Administration (FDA) granting approval for Zevra Therapeutics’ Miplyffa, making it the first treatment for Niemann-Pick disease type C, although this was quickly followed by an FDA nod for Aqneursa, developed by privately-held rare disease specialist IntraBio, for the same condition. Additionally, Bristol Myers Squibb last week announced that the FDA has approved its schizophrenia treatment Cobenfy, previously called KarXT. On the research front, US drug developer IDEAYA Biosciences released new Phase II data on its investigational uveal melanoma drug darovasertib. And US biotech Wave Life Sciences announced positive Phase II data on its Duchenne muscular dystrophy candidate WVE-N531. Also of note, due to safety concerns, US pharma giant Pfizer announced it is withdrawing its sickle cell disease drug Oxbryta from the market. 29 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024