Category: Merck KGaA

  • Merck backs startup bringing AI to fertility treatment

    It’s no secret that fertility treatment is expensive and has a low success rate, placing a big financial and emotional burden on would-be parents. Now, a Canadian biotech aims to tackle that problem though the use of artificial intelligence. Toronto-based Future Fertility has developed an AI called Violet that it says can predict the viability […]

  • Another mRNA company gets snapped up as Merck buys Exelead

    The latest pharma company to make a move for an mRNA specialist is Germany’s Merck KGaA, which has offered a $780 million cash buyout to US biotech Exelead. Unlike other recent deals however the takeover isn’t focused on adding a pipeline of mRNA candidates, as Indianapolis-based Exelead is a contract development and manufacturing organisation (CDMO) […]

  • PharmaShots Weekly Snapshots (November 15 – 19, 2021)

    Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, […]

  • Merck KGaA Collaborated with Burning Rock for Liquid-biopsy Based CDx Development

    Shots: The companies collaborated for CDx development of tepotinib in mainland China. The CDx test is based on Burning Rock’s OncoCompass target which is a self-developed NGS-based liquid biopsy solution Burning Rock will be responsible for the research and development of tumor genetic testing for cancer patients with the precision medicine solutions Tepotinib is an […]

  • GSK bails on $4.2bn partnership with Merck on cancer drug

    GlaxoSmithKline has ended its collaboration with Germany’s Merck KGaA’s cancer treatment bintrafusp alfa, after a trio of failed clinical trials. Given the disappointments the decision to part ways on the programme comes as no surprise, but is nevertheless a setback for GSK which had looked to the drug to revitalise its flagging oncology business. It […]

  • PharmaShots’ Key Highlights of Third Quarter 2021

    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 ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]

  • PharmaShots Weekly Snapshots (August 23 – 27, 2021)

    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, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: […]

  • Third strike for GSK/Merck as bintrafusp alfa flubs again

    GlaxoSmithKline’s big gamble on Merck KGaA’s bintrafusp alfa has gone from bad to worse, after the drug failed yet another mid-stage trial. The latest disappointment has come from the phase 2 [email protected] BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), […]

  • Scotland backs Bavencio for bladder cancer after NICE says no

    Patients with bladder cancer in Scotland will be the first in the UK to claim access to maintenance treatment with Merck Serono and Pfizer’s Bavencio, ahead of their counterparts in England and Wales. The Scottish Medicines Consortium (SMC) has cleared NHS funding for Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial […]

  • Merck’s targeted lung cancer drug tepotinib wins early access in UK

    The UK drugs regulator has backed Merck KGaA’s MET inhibitor for the treatment of some patients with non-small cell lung cancer under the early access to medicines scheme (EAMS). The EAMS – first introduced in 2014 – provides a route for drugmakers to provide earlier availability of promising new unlicensed medicines to patients with few […]

  • Merck partners neuroloop on bioelectronic device for inflammation

    Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices. The German drugmaker will work with startup neuroloop on bioelectronics, put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis […]

  • Inside MoonLake’s raid on Merck KGaA’s inflammatory disease hopeful sonelokimab

    Swiss biotech MoonLake Immunotherapeutics has emerged with what it hopes is one of the hottest drugs in inflammatory diseases, sonelokimab. In an interview with pharmaphorum’s news editor Richard Staines, chief operating officer Arnout Ploos van Amstel revealed how the biotech and its “mystery CEO” managed to swoop for the drug ahead of big pharma rivals. […]

  • NICE says no to Merck Serono’s Bavencio in bladder cancer

    Merck Serono’s Bavencio is the only checkpoint inhibitor to be approved for first-line maintenance treatment of bladder cancer in Europe, but UK cost-effectiveness agency NICE says it is too expensive to justify routine NHS use.  Bavencio (avelumab) was approved in the UK earlier this year for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • MoonLake launches, licensing in Merck KGaA’s Cosentyx challenger sonelokimab

    There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial. MoonLake has swiftly in-licensed the drug discovered […]

  • Avillion/Merck psoriasis nanobody hits the mark in phase 2

    UK biotech Avillion has reported positive mid-stage results with chronic psoriasis drug sonelokimab, which it is developing with Merck KGaA as an alternative to drugs like Novartis’ Cosentyx.  The IL-17A and IL-17F inhibitor hit all its objectives in the phase 2 trial, which has now been published in The Lancet, and showed that it was […]

  • PharmaShots’ Key Highlights of First Quarter 2021

    The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter […]

  • PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

    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 Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of […]

  • PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

    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, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]

  • Merck KGaA Exercises Third Option in its 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 third option to develop an additional bispecific program under the ongoing collaboration with F-star Merck KGaA will be responsible for the development and commercialization of the […]

  • The US FDA New Drug Approvals in February 2021

    The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US […]

  • The US FDA New Drug Approvals in February 2021

    The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US […]

  • PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

    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 and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: […]

  • Merck KGaA Sign an Exclusive Worldwide License Agreement with Debiopharm for Xevinapant

    Shots: Debiopharm to receive $226M up front, ~$853.7M as regulatory and commercial milestones along with royalties. The transaction is expected to close in early Q2’21 Merck KGaA get an exclusive right to develop and commercialize xevinapant globally, including in the US and will co-fund the ongoing P-III TrilynX study that involves assessing Xevinapant vs PBO […]

  • Merck KGaA offloads failed MEK programme to startup Day One

    US biotech Day One has taken ownership of a cancer drug that has been languishing in Merck KGaA’s pipeline for years, in the hope of giving it a new lease of life.  The main object of the deal is Merck’s MEK 1/2 inhibitor pimasertib, a drug it originally licensed from Santhera Pharmaceuticals more than a […]

  • COVID-19 increased demands on carers’ wellbeing, study finds

    COVID-19 has increased demands on informal carers and severely increased demands on their mental, physical and financial wellbeing, according to a global study. Embracing Carers is a global initiative led by Germany’s Merck KGaA and is focused on recognising and raising awareness about the role of informal carers. It intends to develop solutions with global […]

  • Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

    The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the […]

  • PharmaShots Weekly Snapshot (Feb 01-05, 2021)

    Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission […]

  • Merck, Pfizer get EU nod for Bavencio as bladder cancer maintenance

    Pfizer and partner Merck KGaA now have approval on both sides of the Atlantic for their checkpoint inhibitor Bavencio as a first-line maintenance therapy for bladder cancer, stealing a march on rival drugs in a highly competitive market. The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

    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, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the […]

  • GSK/Merck & Co’s hopeful bintrafusp alfa fails in key lung cancer trial

    GlaxoSmithKline’s big gamble on a cancer drug developed by Germany’s Merck KGaA looks unlikely to pay out, after bintrafusp alfa failed to outperform US-based Merck & Co’s Keytruda in a lung cancer trial. GSK had high hopes in 2019 that Merck KGaA’s bintrafusp alfa could be a substantial addition to a pipeline that was in […]

  • Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

    Shots: The companies have launched a multi-year collaboration to bring digital technologies to fertility treatments integrating informatics, mobile ultrasound diagnostics and more The collaboration build on Philips’ expertise in maternal & fetal monitoring, Pregnancy+, Baby+ consumer engagement apps, which provide information on diet and exercise along with updates on the baby’s development The companies will […]

  • PharmaShots’ Key Highlights of Fourth Quarter 2020

    The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated […]

  • PharmaShots Weekly Snapshot (Jan 4-8, 2020)

    Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD    Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, […]

  • Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

    Shots: The acquisition will integrate AmpTec’s PCR-based mRNA technology with Merck’s expertise in lipids manufacturing, providing combine offering across mRNA value chain The deal will expand Merck’s capabilities to develop & manufacture mRNA for use in vaccines, treatments, and diagnostics applicable in COVID-19 and many other diseases. Additionally, AmpTech’s diagnostic business focusing on customized long […]

  • Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

    Shots: Artios to receive $30M up front & near-term milestones, ~$860M/ target as option fee along with royalties on sales of each commercialized product. Additionally, Artios has opt-in rights for joint development & commercialization of the programs Merck has the right to opt into exclusive development & commercialization of compounds on up to 8 targets […]

  • Merck KGaA signs DNA damage response cancer deal with Artios Pharma

    Germany’s Merck KGaA has joined with UK-based Artios Pharma in a potential multi-billion dollar deal to investigate novel DNA damage response targets in cancer. The principle of DNA damage response is already being exploited by AstraZeneca and other companies with their poly (ADP-ribose) polymerase (PARP) inhibitor drugs. These target the inherent genetic instability in certain […]

  • FDA starts quick review of Merck’s MET-targeting lung cancer drug

    Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug. Tepotinib has been developed to treat non-small cell lung cancer (NSCLC) with […]

  • NICE backs kidney cancer combination from Merck KGaA and Pfizer

    NICE has said a combination of Merck KGaA’s Bavencio and Pfizer’s Inlyta should be available as a first line option for kidney cancer patients for NHS patients in England. The cost-effectiveness body okayed interim reimbursement from the Cancer Drugs Fund (CDF) in final guidance for adults with advanced renal cell carcinoma. NICE said that the […]

  • Merck KGaA takes second option from cancer immunotherapy pact with F-Star

    Germany’s Merck KGaA has taken an option on a second cancer immunotherapy drug from its development deal with Anglo-American biotech F-star Therapeutics.  The companies signed a deal to develop cancer immunotherapies in summer 2017, where Darmstadt-based Merck KGaA paid $115 million up front, agreeing to further payments during the first two years of the collaboration and options to buy five of F-star’s bispecific […]

  • 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 […]