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Cadila Pharma Launches NuPTH Biosimilar to Forteo for the Treatment of Osteoporosis in India

Shots: Cadila has launched NuPTH an osteoporosis biosimilar of Forteo in India. The NuPTH is used for the treatment of osteoporosis and in patients with increased risk of fracture. The biosimilar NuPTH aims to be cost-effective for patients and will be available as easy to use, pre-filled disposable pen NuPTH is the third biosimilar launched …

Cadila Pharma Launches NuPTH Biosimilar to Forteo for the Treatment of Osteoporosis in India Read More »

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization

Shots: The US FDA has granted EUA to the Vela’s PCR test that detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs The manual version of the ViroKey enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments but for high throughput testing, an automated version of the …

Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test Receives the US FDA’s Emergency Use Authorization Read More »

Bausch Health to Spin off its Eye Health Business

Shots: Bausch Health spin-off its leading eye health business into an independent publicly-traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21 The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a …

Bausch Health to Spin off its Eye Health Business Read More »

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer

Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC with an EGFR exon 19 deletion or L858R mutation The dose-escalation part will assess the safety & tolerability of different dosing combinations of dual regimen to determine the recommended dose …

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer Read More »

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer

Shots: The P-III IMpassion131 study involves assessing of Tecentriq + paclitaxel vs PBO + paclitaxel, in 651 people in a ratio (2:1) with previously untreated, inoperable, LA/ m-TNBC The study did not meet its 1EPs of PFS for 1L treatment of people with m-TNBC) in the PD-L1+ population.  The data for 2EPs of OS showed …

Roche’s Tecentriq (atezolizumab) + Paclitaxel Fail to Meet the Primary Endpoint in P-III IMpassion131 Study for Patients with Metastatic Triple-Negative Breast Cancer Read More »

Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Shots: Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s Pro-forma outstanding stock along with $1.125B as milestones. The two companies will codevelop Denali’s LRRK2 inhibitor for PD and co-commercialize it in the US and China while Biogen has the right to commercialize the …

Biogen Signs an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B Read More »

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements

Shots: For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate The company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being …

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements Read More »

UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum

Shots: The P-IIIb C-OPTIMISE study assessing Cimzia (200mg, q2w with a loading dose of 400mg @ 0, 2 & 4wks.) vs PBO during 48wks. open-label induction period in adults with early active axSpA. At 48wks., patients in sustained remission (ASDAS <1.3 @wks. 32/36 & 48) were randomized to Cimzia 200mg, q2w (full maintenance dose) & …

UCB’s Cimzia (certolizumab pegol) Receives the EMA’s Approval for a Reduced Maintenance Dose in Patients with Axial Spondyloarthritis Spectrum Read More »

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia

Shots: The company discontinues P-II proof POC study of Lu AF11167 in patients with schizophrenia, who are experiencing persistent negative symptoms (NCT03793712). The P-II study evaluated two doses of Lu AF11167 vs PBO as monothx. in patients with schizophrenia and persistent prominent negative symptoms The discontinuation is based on the results of a futility interim …

Lundbeck Halts P-II Study of Lu AF11167 in Patients with Negative Symptoms of Schizophrenia Read More »

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots: The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites  Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR …

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis Read More »

AstraZeneca Collaborates with Eko to Advance the Digital Health Tools for the Diagnosis of CV Diseases

Shots: The two companies collaborated to facilitate the development of digital health tools for the earlier screening of cardiovascular diseases, including HF AstraZeneca and Eko will accelerate the development of Eko algorithms, enhancing clinical trials with Eko technology, and potentially building new HF detection solutions. The agreement allows the companies to harness the potential to …

AstraZeneca Collaborates with Eko to Advance the Digital Health Tools for the Diagnosis of CV Diseases Read More »

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

Shots: The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global …

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B Read More »

Teva and Alvotech Collaborate to Commercialize Five Biosimilar Candidates in the US

Shots: Alvotech will lead the development, registration, and supply of the biosimilars, while Teva will be exclusively commercializing the products in the US. Alvotech will receive upfront with subsequent milestone payments over the next several years The companies will share the profit from the commercialization of the biosimilars. The collaboration leverages Teva’s commercial presence and …

Teva and Alvotech Collaborate to Commercialize Five Biosimilar Candidates in the US Read More »

Lupin and SunPharma Launch Generic Favipiravir to Treat Mild to Moderate COVID-19 in India

Shots: Lupin has launched favipiravir in India under the brand name ‘Covihalt’ for the treatment of mild to moderate COVID-19 Covihalt will be available as 200mg tablets in the form of a strip of 10 tablets, priced at $0.65 (₹49/tablet) and has received DCGI authorization for emergency use Additionally, SunPharma has launched antiviral drug favipiravir …

Lupin and SunPharma Launch Generic Favipiravir to Treat Mild to Moderate COVID-19 in India Read More »

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots: The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO The dose range was determined based on early …

BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China Read More »

AbbVie Terminates Tau and ASN Agreement with Voyager Signed in 2018 and 2019

Shots: Voyager retains full rights to the vectorization technology and novel vectorized Abs emerges from the collaboration and has the right to pursue vectorized Ab programs targeting tau and alpha-synuclein alone or in collaboration with another partner As per collaboration agreements, Voyager has received an upfront payment to perform research and preclinical development of vectorized …

AbbVie Terminates Tau and ASN Agreement with Voyager Signed in 2018 and 2019 Read More »

Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

Shots: The US FDA has granted de novo class II for cobas EBV test, providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and …

Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients Read More »

LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema

Shots: The US FDA has granted FT designation to LEO’s delgocitinib cream as the potential treatment for adults with moderate-to-severe CHE. There are currently no treatment options available in the US specifically developed and approved for CHE The FDA’s FT designation facilitates the development and expedites the regulatory review of drugs to treat serious conditions …

LEO Pharma Receives the US FDA’s Fast Track Designation for Delgocitinib Cream to Treat Moderate-to-Severe Chronic Hand Eczema Read More »

AstraZeneca Signs a License Agreement with Redx Pharma for RXC006 to Treat Idiopathic Pulmonary Fibrosis

Shots: Redx to receive $17M in early payment by the time of successful commencement of a P-I study, $360M as development, a regulatory and commercial milestone along with royalties on sales of the RXC006 AstraZeneca to get an exclusive global license to further develop & commercialize RXC006 targeting fibrotic diseases including IPF Redx continues to …

AstraZeneca Signs a License Agreement with Redx Pharma for RXC006 to Treat Idiopathic Pulmonary Fibrosis Read More »

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile …

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma Read More »

Siemens Healthineers to Acquire Varian for $16.4B

Shots: Siemens Healthineers to acquire Varian in an all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume-weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B The transaction is expected to be closed in H1’21. The combined company will offer an …

Siemens Healthineers to Acquire Varian for $16.4B Read More »

Merck and Hanmi Collaborate to Develop Efinopegdutide for NASH

Shots: Hanmi to receive $10M up front, $860M as development, regulatory approval, and commercialization of efinopegdutide along with royalties on sales of the approved product Merck to receive an exclusive license to develop, manufacture and commercialize efinopegdutide in the US and globally while Hanmi to retain an option to commercialize the therapy in Korea Efinopegdutide …

Merck and Hanmi Collaborate to Develop Efinopegdutide for NASH Read More »

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19

Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 …

Eli Lilly in Collaboration with NIAID Initiate P-III Study of LY-CoV555 to Prevent COVID-19 Read More »

Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots: The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the …

Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma Read More »

RedHill Replaces its Co-Commercialization Agreement with Daiichi Sankyo for Movantik (naloxegol)

Shots: The new agreement involves, Daiichi to get royalties on sales of Movantik plus payments each year starting from 2021 to 2023. RedHill to take care of all the responsibilities and costs to commercialize Movantik in the US. Additionally, under a subscription agreement Daiichi will get 283,387 shares in RedHill Biopharma as partial consideration in …

RedHill Replaces its Co-Commercialization Agreement with Daiichi Sankyo for Movantik (naloxegol) Read More »

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine The US government has an option to supply an additional 500M dose and helps the government’s Operation …

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine Read More »

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2, P-I STARTRK-1 and P-I ALKA-372-001 trials, and data from the P-I/II STARTRK-NG study in pediatric patients Result: in NTRK fusion+ solid tumors, …

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC Read More »

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Shots: J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected …

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium Read More »

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019 The assay is designed to be completed within the same day, enabling clinicians to get …

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer Read More »

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Shots: The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, …

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome Read More »

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic  (cobimetinib) + Zelboraf (vemurafenib) vs  PBO + Cotellic +   Zelboraf in patients with BRAF V600 mutation-positive advanced melanoma Results: mPFS (15.1 vs 10.6mos.); the safety profile of the Tecentriq combination was consistent with the known safety profiles of the individual medicines. …

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma Read More »

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales of the product. Additionally, Sangamo to take care of certain research and manufacturing activities funded by Novartis Novartis to get exclusive license rights of ZFP-TFs …

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets Read More »

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall …

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes Read More »

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US, EU, South America, Asia, and the Middle East The …

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer Read More »

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and …

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer Read More »

UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Shots: The approval is based on the principle of extrapolation of its efficacy data in adults also supported by pharmacokinetic and safety data in children. Additionally, the safety and tolerability data of Brivlera in children 4 years and older were similar to observed in adults The usage of Brivlera in pediatric and adolescent patients is …

UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients Read More »

BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Shots: Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, …

BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness Read More »

Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Shots: The companies expanded the collaboration to support the needs of patients with kidney disease via digital health solutions. The agreement integrates Ayogo’s LifePlan digital platform with Baxter’s expertise in renal care to develop mobile apps and digital solutions that bring personalized and timely support to patients with kidney failure Baxter made an equity investment …

Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis Read More »

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Shots: The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical …

Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma Read More »

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks. Results: @16wks. EASI 75 (65%/77% vs 26%); vIGA-AD 0/1 (40%/59% …

AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis Read More »

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Shots: The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post-randomization The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs …

Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia Read More »

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Shots: The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19 Sanofi leads the clinical development and registration of the vaccine and expects a P-I/II study to be initiated in Sept’2020, followed by a P-III study by the end of 2020. Additionally, the companies are …

Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine Read More »

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Shots: The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative diseases) and c) 622 in Colombia (365 with E280A mutations and 257 …

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease Read More »

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Shots: UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development, and commercial milestones as well as royalties on sales of the therapies, if Roche proceeds the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD UCB to fund and perform a POC study in …

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease Read More »

Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for suspected breast lesions. The HealthMammo product then returns its result …

Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool Read More »

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary albumin excretion, with and without T2D The study met its 1EPs i.e. worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, the …

AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease Read More »

Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains all rights to fruquintinib outside of China The agreement allows …

Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China Read More »

AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Shots: Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation The two companies may enter additional commercial manufacturing agreement as the candidate progresses over three years through Emergent’s …

AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19 Read More »

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 …

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19 Read More »

PharmaShots Celebrates Successful Accomplishment of Two Years

Shots: PharmaShots started its journey in July 2018 as a concise news delivery service and is proud to announce the completion of two years, with many more to come. Till now, PharmaShots has published 3,057 posts delivered to our 3000+ subscribers On the 2nd anniversary, PharmaShots announced “PharmaShots Bespoke” its new tailor-made, and targeted news …

PharmaShots Celebrates Successful Accomplishment of Two Years Read More »

Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Shots: Jenburkt became the second company to launch Favivent (favipiravir) to treat mild to moderate COVID-19 symptoms at a price of ​Rs. 39/tablet Cipla receives the DCGI approval for Ciplenza (favipiravir, 200mg) targeting the unmet medical needs for COVID-19 treatment options in the country through restricted emergency use. The company will launch Ciplenza in the …

Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India Read More »

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87% patients responded to Tecartus (single infusion), including 62 % patients …

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL Read More »

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix Equidacent will be available as 25 mg/ml as the …

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications Read More »

AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Shots: Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B The companies will jointly develop and commercialize DS-1062 globally and …

AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B Read More »

Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Shots: Sorrento enters into letter of intent to acquire SmartPharm and develops pipeline of gene-encoded therapeutic Ab, initiating with Sorrento’s STI-1499 or COVI-GUARD, currently preclinical studies with an IND submission targeted for Aug’2020. The transaction is expected to be close in Aug’2020. The integration of Sorrento’s G-MAB Ab library and SmartPharm’s GET platform is expected …

Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer Read More »

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis

Shots: Then CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs  In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage …

Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Read More »

Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Shots: Synaffix to receive upfront, milestone and royalty payments tied to each program while ADC gets a non-exclusive right for two additional programs, bringing the total number of programs to five ADC also get access to Synaffix’ GlycoConnect platform, including DAR1 technology enabling stable attachment of just a single drug per antibody In 2016, the …

Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Read More »

Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Shots: Zydus has received the US FDA’s approval to initiate clinical trials of Desidustat in CIA. The company has initiated two P-III studies of desidustat The P-III DREAM-ND (NCT04012957) study is being conducted in 588 CKD patients not-on-dialysis while the P-III DREAM-D is being conducted in 392 CKD patients on dialysis (NCT04215120) The therapy met …

Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA) Read More »

AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with mod. to sev. COPD and a history of exacerbation(s) in the previous year The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. …

AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD Read More »

Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Shots: The US FDA approves Abbott’s patient controller app for use on Apple’s smartphone devices, allowing patients with neurological conditions such as chronic pain or movement disorders to manage their therapy directly from their smartphone The company plans to integrate the app into Abbott’s NeuroSphere Digital Care, launched in May’2020 which is compatible with Infinity …

Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder Read More »

BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Shots: The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The …

BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia Read More »

Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Shots: Ovid will collaborate with UConn’s Stormy J. Chamberlain and secures exclusive access to identified genetic sequences for shRNA-based therapy. Ovid plans to leverage its translational medicine capabilities and drug development expertise in Angelman syndrome to advance OV101 into clinical Ovid is developing OV101 for Angelman syndrome to restore tonic inhibition addressing several core symptoms …

Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome Read More »

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots: The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, …

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration Read More »

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Shots: The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19 Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in the overall population as measured by the median time until …

Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19 Read More »

Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Shots: Gustave Roussy to receive funding and support from Daiichi Sankyo for integrative research program including clinical, translational, and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer respectively The research program includes two P-II studies evaluating the efficacy, safety, and markers of response and resistance to DS-1062 & patritumab deruxtecan in …

Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer Read More »

Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Shots: The collaboration will deploy Biofourmis’ Biovitals platform to co-develop a novel digital technology for the objective assessment of pain using biosensors and AI-based algorithms. The solutions will be validated in the global study that enrolls 120+ endometriosis patients The digital solution for managing patients with endometriosis in an ambulatory setting will include a wearable, …

Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain Read More »

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met its co-1EPs @16wks. i.e. improvement in EASI 75 (60%/73% vs …

AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis Read More »

Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Shots: The two companies collaborated to discover and develop novel therapeutics interfering with the disease-causing transcriptional programs in cancer and other diseases. Quantro intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts Quantro will exploit its functional-genetic and transcriptomic technologies addressing the undruggable targets while Evotec will …

Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases Read More »

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Shots: The approval is based on 12mos. results of PINNACLE FLX study assessing the WATCHMAN FLX device as an alternative to NOACs and other OAC medications. The study met its 1EPs demonstrating a low rate of major procedure-related safety events (0.5% @7days post-procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm …

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device Read More »

Gilead to Acquire Tizona’s Stakes for $300M

Shots: Gilead invests $300M to obtain 49.9% equity interest in Tizona and receives an exclusive option to acquire remaining stakes of Tizona for up to an additional $1.25B that includes an option exercise fee and milestones. The transaction is expected to be closed in Q3’20 Gilead can exercise its option following the results of a …

Gilead to Acquire Tizona’s Stakes for $300M Read More »

Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Shots: The two companies collaborated to develop and distribute innovative digital therapeutics supporting people with diabetes on biologics therapy. The collaboration allows Biocon to offer Insulia to T2D patients across several markets globally Biocon aspires to reimagine the patient ecosystem by developing a technology-dependent operating model enabling personalization of care, thus going beyond the product …

Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins Read More »

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Shots The FullFocus viewer allows pathologists to view and navigate images when used together with the Philips’ Ultra-Fast scanner. The AI firm is working to expand the 510(k) clearance to include the use of FullFocus with additional scanners and monitors in future In Nov’2019, FullFocus received the CE Mark, making it available to use in …

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology Read More »

The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Shots: UK Rapid Test Consortium’s (UK-RTC) finger prick test passes its first major trial that delivers results in 20mints. and demonstrate 98.6% accuracy in its clinical study. The AbC-19 lateral flow test is the first approved Ab test for Covid-19 in the UK that generates an instant result The clinical trial involves ~300 people and …

The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19 Read More »

Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Shots: Jnana to receive $40M upfront payment in cash and is eligible to get ~$1B as research funding, preclinical, development, and commercialization milestone along with royalties on sales of the therapies The partners will work on the discovery and preclinical development of therapies targeting key regulators of cellular metabolism to treat across immunology and neuroscience …

Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases Read More »

Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Shots: Mylan launches Desrem (remdesivir) addressing the unmet needs amid COVID-19. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalized with severe symptoms Mylan will manufacture Desrem in its state-of-the-art injectable facility in Bangalore, India, and other export markets where Mylan has received a license …

Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India Read More »

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, …

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19 Read More »

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK The study demonstrated …

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19 Read More »

Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Shots: PTC Therapeutics to receive $650M as upfront in cash in exchange for ~43% of the risdiplam royalties, up to a specified amount while PTC maintains the majority of the risdiplam royalty stream and retains all economics associated with up to ~$400M in remaining regulatory and commercial milestones The collaboration enables PTC to further develop …

Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M Read More »

Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Shots: The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA …

Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19 Read More »

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Shots: The real-world evidence partnership will allow the Roche to access PicnicHealth’s set of de-identified patient records to gain insights on certain diseases and treatments The collaboration will initially focus on MS and may be extended to support Huntington’s disease (HD), paroxysmal nocturnal hemoglobinuria (PNH), and hemophilia The companies signed a multi-year collaboration that combines …

Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis Read More »

Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Shots: The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19 The trial is expected to be completed in …

Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea Read More »

GSK to Acquire 10% stake in CureVac for $163M

Shots: GSK will invest $163M (€150m) in CureVac for a 10% stake to collaborate for the research, development, manufacturing, and commercialization of up to five mRNA-based vaccines and mAbs targeting infectious disease pathogens excluding CureVac’s existing COVID-19 mRNA and rabies vaccines research programs CureVac to receive $137M (€120m) as upfront, $34.3 (€30m) as one-time reimbursable …

GSK to Acquire 10% stake in CureVac for $163M Read More »

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg …

Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Read More »

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and …

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/ Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors Read More »

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Shots: Under the amended agreement, the offer price increased from $44.5 to $49/QIAGEN share in cash, representing a premium of 35% to the closing price of QIAGEN’s ordinary shares on the Frankfurt Prime Standard on Mar 2, 2020, making the latest deal value as $12.5B The amendment also provides for a reduction of the minimum …

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN Read More »

Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Shots: The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis, which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020 Earlier, the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy …

Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis Read More »

Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

Shots: F-star to receive option exercise payment and will be eligible to get milestones and royalties on net sales of therapies resulting from the collaboration. Merck KGaA exercises its option to license a preclinical program in its existing agreement with F-star Merck KGaA will be responsible for the development and commercialization of the preclinical program …

Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star Read More »

Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Shots: Gilead to receive an up front in cash and convertible notes into Kronos equity, regulatory & commercial milestones along with royalties on sales of products emerges from the acquired programs Kronos to acquire the two clinical-phase assets along with the rest of Gilead’s portfolio of SYK inhibitors. The portfolio includes entospletinib, being evaluated in …

Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio Read More »

Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event The 1EPs is the composite of time to the …

Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF Read More »

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20 The 1EPs od the study will be ORR while the 2EPs include OS, PFS, [email protected], one-year survival …

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer Read More »

NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

Shots: NCCN and Pfizer have issued an open RFP that develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centers, patient advocacy groups and …

NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology Read More »

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches …

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India Read More »

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Shots: The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in 11,000 patients with non-cardioembolic acute ischaemic stroke or high-risk TIA for 30days Results: 17% reduction in 1EPs of stroke and death, 21% reduction in 2EPs of ischaemic stroke, the risk …

AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack Read More »

Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Shots: Novartis will offer a portfolio of 15 generic and OTC medicines addressing the need of low- and lower-middle-income countries to treat patients with COVID-19 symptoms. The medicines will available governments, NGOs, and other institutional customers in up to 79 countries at zero-profit to support financially strained healthcare systems The Novartis’ COVID-19 portfolio aid to …

Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19 Read More »