FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials
China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment […]
China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment […]
Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. […]
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, […]
Shots: The SURPASS-4 study evaluates the efficacy & safety of tirzepatide (5/10/15mg) vs insulin glargine in 2002 adults in a ratio (1:1:1:3) with T2D inadequately […]
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: […]
Shots: The P-III monarchE trial assessed Verzenio (150mg, bid) + SOC vs SOC alone in patients with EBC in a ratio (1:1) for 2yrs. Patients […]
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, […]
Shots: The approval is based on P-III BEACON CRC trial evaluating Braftovi (300mg, qd) + Erbitux vs irinotecan + Erbitux or Folfiri + Erbitux in […]
Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, […]
Shots: Lycia to receive $35M up front and is also eligible to receive an additional ~$1.6B upon the achievement of milestones along with royalties on […]
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, […]
Shots: The ongoing P-III ADvocate 1 & 2 studies evaluate lebrikizumab as monothx. vs PBO in adult & adolescent patients aged 12 to less than […]
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
Shots: Kumquat to receive an ~ $70M in upfront and an equity investment in addition to ~$2B in milestone based on the achievement of definite […]
Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, […]
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: […]
Shots: The approval is based on P-III ORIENT-12 trial evaluating Tyvyt (sintilimab injection) or PBO + Gemzar (gemcitabine) & platinum CT in 357 patients in […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
Shots: SURPASS-4 study involves assessing tirzepatide (5/10/15mg) vs insulin glargine in 2002 adults in a ratio (1:1:1:3) with T2D inadequately controlled with at least 1 […]
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
Shota: MiNA to receive $25M as up front and is eligible to receive $245M as milestones for each of five potential targets along with royalties […]
Shots: AbCellera reported that a second Ab from its collaboration with Lilly, LY-CoV1404 has entered clinical trials in patients with mild-to-moderate COVID-19. The program will […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
Shots: The P-III COV-BARRIER study involves assessing Baricitinib (4mg, qd) + SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) […]
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal […]
Shots: The P-III ORIENT-3 trial involves assessing the efficacy and safety of Tyvyt (sintilimab) vs docetaxel (q3w) in 290 patients in a ratio (1:1) as […]
Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, […]
Shots: The approval is based on P-III study involves assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, […]
After more than a decade of fraught clinical development it looks like the end of the line for Pfizer/Lilly painkiller tanezumab, which promised to be […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, […]
Shots: Biolojic to receive ~$121M including development and commercialization milestones and a promissory note that may be convertible into Biolojic equity in future Additionally, Biolojic […]
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
Shots: The P-III SURPASS-2 trial involves assessing Tirzepatide (5/10/15mg) vs Semaglutide (1mg) in 1,879 patients in a ratio (1:1:1:1) with T2D inadequately controlled with ≥1500 […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
Shots: The companies collaborated to get a new version of the BlueStar insulin management app that integrates insulin dosing data for several of Lilly’s insulins […]
RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and […]
Shots: The P-lll SURPASS-3 study involves assessing Tirzepatide (5/10/15 mg) vs titrated insulin degludec in 1444 participants in a ratio (1:1:1:1) with T2D treated with […]
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, […]
Shots: Asahi Kasei to receive an $20M up front, ~$210M as development & regulatory milestones and will be eligible for ~$180M milestones along with royalties […]
Shots: Lilly has expanded its ongoing BLAZE-4 trial to assess the administration of bamlanivimab (700mg) with VIR-7831 (500mg) for symptomatic COVID-19 in the outpatient setting. […]
Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, […]
Shots: Merus to receive $40M up front, $20M as an equity investment, ~$540M as development & commercial milestones making it a total of $1.6B for […]
Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals […]
Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni […]
Shots: Lilly to acquire Prevail for $22.50/ share in cash (~ $880M) payable at closing plus one non-tradable CVR worth up to $4.00/ share in […]
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, […]
Shots: The P-lll SURPASS-1 study involves assessing Tirzepatide as monothx. (5/10/15 mg) vs PBO in 478 patients in the ratio of (1:1:1:1) with T2D inadequately […]
Shots: Precision to receive $100M upfront, $35M as an equity investment and will receive $420M as milestones/ product along with royalties on sales of licensed […]
Shots: The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second […]
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and […]
Shots: The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the […]
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Shots: The 7 studies include one Proffered Paper Oral Presentation & 6 e-posters, covering indications including lung cancer, liver cancer, gastric cancer, & esophageal cancer […]
Shots: The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms […]
The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation […]
Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, […]
Shots: The approval is based on P-lll COAST-X study assessing Taltz (80mg, q4w) vs PBO for the treatment of adult patients with nr-axSpA with objective […]
Shots: The companies shared the additional efficacy and safety data of the ACTT-2 study demonstrating baricitinib + remdesivir reduced time to recovery and improved clinical […]
Shots: The companies will partner to promote Lyumjev (insulin lispro-aabc injection, 100 & 200 units/mL) with Dexcom G6 CGM to aid HCPs in the US […]
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, […]
Shots: Innovent to receive $200M up front, $825M as development and commercial milestones along with royalties on net sales of the therapy. Both the companies […]
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