Shots:Enlaza & Vertex’s muti-target collaboration will leverage Enlaza’s War-Lock platform to develop small format drug conjugates & T-cell engagers for autoimmune diseases & improved conditioning in sickle cell disease & β thalassemiaEnlaza will receive $45M in upfront & equity investment & is eligible for >$2B in research, development, regulatory, & commercial milestones plus…
Shots:Vertex announced topline results from its P‑II study of selective NaV1.8 inhibitor VX‑993 in 367 pts with acute pain post-bunionectomy; VX‑993 did not achieve a statistically significant improvement in SPID48 vs placeboVX‑993 was safe and well tolerated at all doses, with AEs mostly mild/moderate; no SAEs related to VX‑993 and no discontinuations due…
Shots:The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults
JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels
The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…
Shots: The US FDA has approved Alyftrek (QD, CFTR modulator) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one F508del mutation or another CFTR gene mutation. Submissions are under review in the EU, UK, Canada, Switzerland, Australia & New Zealand Approval was supported by pivotal P-III CF program involving >1,000 patients across…
Shots:The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9BThis quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…
Shots:The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industryIn November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…
Shots:The EMA approved 8 New Chemical Entity (NCE) and 3 Biologic Drugs in April 2023, leading to treatments for patients and advances in the healthcare industryIn April 2023, the major highlights drugs were Rinvoq’s Approval for active Crohn's Disease, Opzelura for non-segmental vitiligo with facial involvement in adults and adolescentsPharmaShots has compiled…
Shots:The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…
The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fractionStarting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229MThe key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…

