Merck

Engage at HLTH: At the heart of patient-centered care is trust and knowledge

Panelists at HLTH’s patient engagement track, hosted by MedCity News, zeroed in on three strategies for achieving patient centricity: building trust, engaging health navigators and providing easy-to-understand health information.

PharmaShots Weekly Snapshots (October 11 – 15, 2021)

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: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer

Shots: The US FDA has approved Keytryda + CT, with/out bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test The approval is based on the P-III KEYNOTE-826 trial that demonstrated superior OS and PFS, ORR (68% vs 50%), mDOR …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer Read More »

Merck and Ridgeback Report EUA Submission to the US FDA for Molnupiravir to Treat COVID-19

Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & symptom onset within 5 days before randomization The interim analysis showed ~50% reduction in risk of hospitalization or death; patients who received therapy were either hospitalized or died @29 Days …

Merck and Ridgeback Report EUA Submission to the US FDA for Molnupiravir to Treat COVID-19 Read More »

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

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, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …

PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »

Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19

Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in 1550 non-hospitalized adult patients with COVID-19 with at least one risk factor associated with poor disease outcomes & symptom onset within 5 days before randomization At the interim analysis, ~50% reduction in the risk of hospitalization or death; patients who received the therapy were either …

Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Read More »

Merck to buy Acceleron for $11.5B; cardio drug could cushion fall from Keytruda cliff

Merck is looking for products that diversify its portfolio beyond reliance on cancer drug Keytruda, and it sees a potential blockbuster cardiovascular drug from Acceleron Pharma as fitting the bill. The pharma giant is paying $11.5 billion to acquire the biotech, and executives say they’re still on the hunt for more deals.

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’ Key Highlights of Third Quarter 2021 Read More »

Merck to Acquire Acceleron for ~$11.5B

Shots: Merck to acquire Acceleron for $180/share in cash making a total equity value of ~$11.5B representing a premium of 2.6% to the stock’s closing price. The transaction is expected to close in Q4’21 The acquisition will strengthen Merck’s cardiovascular pipeline. Acceleron’s sotatercept is currently in P-III trials & has the potential to improve short-term …

Merck to Acquire Acceleron for ~$11.5B Read More »

PharmaShots Weekly Snapshots (September 20 – 24, 2021)

Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer

Shots: The P-III KEYNOTE-826 trial evaluates Merck’s Keytruda (200mg, IV, q3w for up to 35 cycles) + Pt-based CT vs PBO + CT with/out bevacizumab in 617 patients aged b/w 22- 82yrs. with persistent, recurrent, or metastatic cervical cancer The results showed a 33% reduction in the risk of death; m-OS (24.4 vs 16.5mos.), m-PFS …

Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-826 Trial as 1L Treatment for Cervical Cancer Read More »

Insights+: The US FDA New Drug Approvals in August 2021

The US FDA has approved 3 BLAs and 2 NDAs in 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 48 novel products in 2021 Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in August 2021 Read More »

Merck Enters into a Clinical Collaboration with Hookipa to Evaluate Keytruda (pembrolizumab) + HB-200 as 1L Treatment of Advanced Head and Neck Cancers

Shots: The companies collaborated to evaluate Hookipa’s HB-200 (arenaviral immunotherapeutic) + Merck’s Keytruda (anti-PD-1 therapy) in a P-II trial for patients with advanced HNSCC, based on an ongoing P-I/II trial of HB-200 for advanced HPV16+ cancers patients HB-201 monothx. showed an ORR (18%), m-PFS (3.45mos.) in heavily pretreated head & neck cancer patients. Preliminary data …

Merck Enters into a Clinical Collaboration with Hookipa to Evaluate Keytruda (pembrolizumab) + HB-200 as 1L Treatment of Advanced Head and Neck Cancers Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

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: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

Merck Reports Results of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in P-III PNEU-PED Study for the Prevention of Invasive Pneumococcal Disease

Shots: The P-III PNEU-PED study evaluates immunogenicity, safety & tolerability of Vaxneuvance (4-dose regimen) vs PCV13 in 1720 infants aged b/w 42-90 days with IPD Vaxneuvance showed a non-inferior immune response to PCV13 for 12 & 13 shared serotypes @ 30days, following PD3 & for all 13 based on serotype-specific IgG GMCs, following PD4. The …

Merck Reports Results of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in P-III PNEU-PED Study for the Prevention of Invasive Pneumococcal Disease Read More »

Top 7 Pharma Industry Leaders in 2020 By the Numbers

Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic …

Top 7 Pharma Industry Leaders in 2020 By the Numbers Read More »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

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, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 …

PharmaShots Weekly Snapshots (August 16 – 20, 2021) Read More »

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies

Shots: The companies collaborated to evaluate ADG106 + Keytruda in dose-escalation and expansion clinical study to treat advanced or metastatic solid tumors & hematological malignancies In preclinical studies, ADG106 showed antitumor activity and was well tolerated as a monothx. and in combination with other immuno-oncology therapies ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 IgG4 …

Merck Enters in Third Clinical Trial Collaboration with Adagene to Advance ADG106 + Keytruda (pembrolizumab) for Solid Tumors and Hematological Malignancies Read More »

Merck Reports the Initiation of Rolling Submission to Health Canada for Molnupiravir to Treat COVID-19

Shots: The initiation of a rolling submission to Health Canada for molnupiravir (bid, for 5 days) to treat COVID-19 is based on the P-II interim results from the P-II/III MOVe-OUT clinical trials. The therapy is being developed in collaboration with Ridgeback The submission was accepted under the Minister of Health’s interim order and enables the …

Merck Reports the Initiation of Rolling Submission to Health Canada for Molnupiravir to Treat COVID-19 Read More »

Merck drug acquired in $1B deal approved to treat tumors sparked by rare disease

FDA approval of the Merck drug, belzutifan, covers treatment of tumors caused by von Hippel-Lindau disease, an inherited disorder associated with several types of cancer. Merck added the small molecule to its pipeline two years ago as part of a $1.2 billion acquisition.

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021) Read More »

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, qd) vs sunitinib (50 mg, q4w) in a ratio (1:1:1) in 1,069 patients with advanced RCC The results demonstrated an improvement in PFS with a …

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma Read More »

Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

Shots: The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg, q3w) in 90 patients with MSI-H/dMMR advanced EC with disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation This indication is approved under accelerated …

Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma Read More »

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC

Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with RCC, following nephrectomy and resection of metastatic lesions The results demonstrated an improvement in DFS and were presented at ASCO 2021 with an anticipated PDUFA …

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC Read More »

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

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 Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma

Shots: The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected high-risk melanoma. The anticipated PDUFA date for the therapy is Dec 04, 2021 The trial met its 1EPs of RFS with no new safety signals observed. Based on this data, …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma Read More »

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes

Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 adults aged >18yrs. with IPD caused by 15 serotypes Results: Vaxneuvance showed a non-inferior immune response to PCV13 for 13 shared serotypes as assessed by OPA GMTs & superior immune …

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes Read More »

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

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, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July …

PharmaShots Weekly Snapshots (July 05 – 09, 2021) Read More »

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma

Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint therapy across the US, Canada, EU & Australia The companies will responsible for internal costs with OncoSec covering the third-party costs. The trial is intended …

Merck Collaborates with OncoSec to Evaluate TAVO (tavokinogene telseplasmid) + Keytruda (pembrolizumab) in P-III KEYNOTE-C87 Trial for Late-Stage Metastatic Melanoma Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma

Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA cSCC that is not curable by surgery or radiation Results: ORR (50%); CR (17%); PR (33%), 81% had DOR of 6mos. or longer, and 37% …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Expanded Indication in Patients with Locally Advanced Cutaneous Squamous Cell Carcinoma Read More »

Merck Amends Collaboration with NGM to Advance Novel Therapies for Retinal and CVM Diseases

Shots: NGM to receive ~ $120M as research & development funding through Mar’24, including ~$86M for the period from Apr’21 through Mar’22 & additional option payments if Merck exercises license option The collaboration will initially focus on retinal and CVM diseases with NGM621 and MK-3655. Merck retains its option to license NGM621, currently being evaluated …

Merck Amends Collaboration with NGM to Advance Novel Therapies for Retinal and CVM Diseases Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

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 agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck to Evaluate LNS8801 + Keytruda for the Treatment of Patients with Advanced Cancer

Shots: Linnaeus will conduct 6 additional P-II cohorts evaluating LNS8801 + Keytruda in several cancer indications while the companies are currently evaluating the combination in patients who had previously responded to PD-1/L1 therapy and also LNS8801 as a monothx in patients unable to tolerate PD-1/L1 therapy due to serious immune-related AEs The companies will further …

Linnaeus Therapeutics Reports the Expansion of Clinical Collaboration with Merck to Evaluate LNS8801 + Keytruda for the Treatment of Patients with Advanced Cancer Read More »

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir to Treat COVID-19

Shots: Merck to receive ~$1.2B to supply ~1.7M courses of molnupiravir to the US government, if its receives EUA or approval from the US FDA and expects to have 10M+ courses of therapy available by the end of 2021 The therapy is currently being evaluated in a P-III MOVe-OUT study in non-hospitalized patients with COVID-19. …

Merck Signs ~$1.2B Supply Agreement with US Government for Molnupiravir to Treat COVID-19 Read More »

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

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: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …

PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021

Shots: The P-III KEYNOTE-564 evaluating Keytruda monothx (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) vs PBO in 950 patients with RCC, following nephrectomy & resection of metastatic lesions Results: @ median follow-up of 24.1 mos., 32% reduction in the risk of disease recurrence or death, a favorable trend …

Merck Presents Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 as Adjuvant Therapy for Renal Cell Carcinoma at ASC0 2021 Read More »

PharmaShots Weekly Snapshots (May 24 – 28, 2021)

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 Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

Merck Signs a Clinical Trial Collaboration with Xilio for Anti-CTLA-4 Monoclonal Antibody Program

Shots: The companies collaborated to evaluate XTX101 + Keytruda for patients with solid tumors. The planned P-I study will be conducted by Xilio and is designed to evaluate the safety & efficacy of XTX101 as a monothx. and in combination with Keytruda for solid tumors Xilio plans to submit an IND for XTX101 to the …

Merck Signs a Clinical Trial Collaboration with Xilio for Anti-CTLA-4 Monoclonal Antibody Program Read More »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

PharmaShots Weekly Snapshots (May 03 – 07, 2021) Read More »

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R

Shots: The collaboration will evaluate Fusion’s FPI-1434 + Merck’s Keytruda in patients with solid tumors expressing IGF-1R. Fusion will sponsor the study and Merck will supply Keytruda The companies plan to initiate a P-I/II trial to evaluate the safety, tolerability, and PK of combination therapy and is expected in ~6 to 9 mos. upon achieving …

Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + Keytruda (pembrolizumab) to Treat Solid Tumors Expressing IGF-1R Read More »

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma

Shots: The 1st sNDA and sBLA is based on results from the P-III CLEAR Study evaluating Lenvima + Keytruda or in combination with everolimus vs sunitinib in a ratio (1:1:1) in 1,069 patients with advanced RCC, demonstrated improved PFS, OS, and ORR The 2nd application is based on results from the P-III KEYNOTE-775/Study 309 trial …

Merck and Eisai Receive the US FDA‘s Priority Review for Keytruda (pembrolizumab) + Lenvima (lenvatinib) Applications to Treat Advanced Renal Cell Carcinoma and Endometrial Carcinoma Read More »

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’ Key Highlights of First Quarter 2021 Read More »

Merck’s Covid-19 drug R&D falls short twice in treating hospitalized patients

Merck is discontinuing work on one Covid-19 drug for treating hospitalized patients after the FDA said it needs more clinical data. Another Merck drug candidate is moving forward only in outpatient testing after independent clinical trial observers concluded the antiviral was unlikely to help those in the hospital.

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 …

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021) Read More »

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma

Shots: The P-III KEYNOTE-564 trial involves assessing Keytruda (200 mg, IV, on day1 of each 3wks. cycle for up to 17 cycles) as adjuvant therapy vs PBO in 950 patients with RCC, following nephrectomy and resection of metastatic lesions The study showed improvement in 1EPs i.e DFS while the trial will continue to evaluate its …

Merck Report Results of Keytruda (pembrolizumab) in P-III KEYNOTE-564 Trial as Adjuvant Treatment for Renal Cell Carcinoma Read More »

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

Shots: The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg, PO, qd) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and did not require immediate surgery Results: It showed ORR of 36.1% while the 2EPs include DCR, DoR, time to response, …

Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC Read More »

Gilead Collaborates with Merck to Jointly Develop and Commercialize Lenacapavir + Islatravir for HIV

Shots: The companies will co-develop & co-commercialize the combination of Gilead’s Lenacapavir and Merck’s Islatravir in long-acting oral & injectable formulations for HIV. Gilead & Merck will share global development & commercialization costs (60%/40%) respectively For oral products, Gilead will lead commercialization in the US & Merck will lead in the EU & ROW while …

Gilead Collaborates with Merck to Jointly Develop and Commercialize Lenacapavir + Islatravir for HIV Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

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: …

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »

Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough

Shots: The NDA submission is based on two P-III studies (COUGH-1 & -2) involves assessing gefapixant (45/15mg, bid) vs PBO in 2,044 patients with RCC & UCC In both the studies, gefapixant resulted in the reduction of in 24hrs.-cough frequency @12 & 24wks respectively. Data were presented at ERS 2020 Gefapixant is a selective P2X3 …

Merck Reports the US FDA’s Acceptance of NDA for Review of Gefapixant to Treat Refractory or Unexplained Chronic Cough Read More »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

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, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Merck to Acquire Pandion for ~$1.85B

Shots: Merck to acquire all outstanding share of Pandion for $60/share in cash, representing the equity value of ~$1.85B. The transaction is expected to close in H1’21 The acquisition will strengthen Merck’s portfolio with the addition of candidates targeting a broad range of autoimmune diseases Pandion is advancing a pipeline of precision immune modulators targeting …

Merck to Acquire Pandion for ~$1.85B Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

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 Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

PharmaShots Weekly Snapshots (Feb 15- 19, 2021) Read More »

Pharma’s pipeline continues to provide drama as investors look beyond COVID in Q4

While the pandemic has been the focus of R&D attention for much of 2020, that is slowly beginning to shift towards other projects in the big pharma pipeline. pharmaphorum’s news editor, Richard Staines, discusses the success stories and failures in R&D that have emerged during the Q4 results period.  Quarterly results announcements are a good …

Pharma’s pipeline continues to provide drama as investors look beyond COVID in Q4 Read More »

The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 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 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved …

The US FDA New Drug Approvals in January 2021 Read More »

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 …

PharmaShots Weekly Snapshot (Feb 01-05, 2021) Read More »

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Shots: The P- III trial involves assessing of Keytruda in combination with ipilimumab vs Keytruda monothx in 568 patients in a ratio (1:1) as 1L treatment for metastatic NSCLC patients without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1 Results: @ median follow-up (20.6 mos.); mOS (21.4 vs 21.9 mos.); mPFS (8.2 …

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

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, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

Merck Signs an Exclusive Worldwide License Agreement with Artiva to Develop CAR-NK Cell Therapies

Shots: Artiva to receive $30M up front for the first 2 programs & an additional $15M, if Merck exercises its option for a third program. Artiva to get ~$612M/ program as development & commercial milestones and royalties on the global sales of the product emerge from the collaboration Artiva receives funding from Merck for each …

Merck Signs an Exclusive Worldwide License Agreement with Artiva to Develop CAR-NK Cell Therapies Read More »

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Shots: The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg, q3w) vs CT regimen in 307 patients in a ratio (1:1) with previously untreated metastatic MSI-H or dMMR colorectal cancer Results: reduction in the risk of disease progression or death by 40%, median PFS (16.5mos. vs 8.2mos); ORR (44% vs …

Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer Read More »

Insights+: Key Deals of JP Morgan Healthcare Conference 2021

This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …

Insights+: Key Deals of JP Morgan Healthcare Conference 2021 Read More »

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 …

PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) Read More »

Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …

Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in …

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure Read More »

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’ Key Highlights of Fourth Quarter 2020 Read More »

Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology

Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.

Top 20 Biopharma M&A of 2020 by Total Deal Value

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 of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% …

Top 20 Biopharma M&A of 2020 by Total Deal Value Read More »

PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. …

PharmaShots’ Most Read News of 2020 Read More »

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, …

PharmaShots Weekly Snapshots (Dec 21-23, 2020) Read More »

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology

Shots: Janux to receive up to $500.5M/ target as upfront and milestones along with royalties on sales of product emerges from the collaboration, making a total deal value ~$1B. Merck will fund R&D performed under the agreement Merck to get an exclusive WW license to products & IP developed from the collaboration The focus of …

Merck Signs a ~$1B Pact with Janux to Develop Cancer Therapies Using T Cell Engager Technology Read More »

KaliVir, Astellas licensing deal; AbCellera’s IPO; Bayer CAR-T Cell therapy collab with Atara; Aligos, Merck together against NASH

KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.  As its lead program, KaliVir is developing VET2-L2 leveraging its unique technology …

KaliVir, Astellas licensing deal; AbCellera’s IPO; Bayer CAR-T Cell therapy collab with Atara; Aligos, Merck together against NASH Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) Read More »

Merck Collaborates with Siemens for the Digitalization of Production

Shots: The collaboration focuses on advancing modular production in the industry. A first state-of-the-art, modular plant in the production environment is to be built at the Darmstadt site of Merck by 2022 Merck to invest ~$11.93M in the realization of the plant under the $1.1B investment program announced in Darmstadt up until 2025. It will …

Merck Collaborates with Siemens for the Digitalization of Production Read More »

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Shots: The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy With the validation, the application is complete, and the EMA will now initiate the review procedure. Tepotinib is an oral MET inhibitor that inhibits …

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations Read More »

Merck to Acquire OncoImmune for $425M

Shots: Merck to acquire all outstanding shares of Oncolmmune for $425 M in cash as an upfront. Additionally, Oncolmmune will receive sales-based and contingent payments on the achievement of the regulatory milestones The acquisition will give Merck control of CD24Fc which showed improvement in an interim efficacy analysis of a P-III study for the treatment …

Merck to Acquire OncoImmune for $425M Read More »

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

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 Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

PharmaShots Weekly Snapshots (Nov 09-13, 2020) Read More »

Top 20 Animal Health Companies Based on 2019 Revenue

Healthy animals contribute to the elimination of hunger and sustainable food production. The diseases that affect animal health also affect humans. Tackling them while they are present in animals not only safeguards our health, but it is also easier, more effective, and less expensive to address. Monitoring animal health and preventing animal disease outbreaks is …

Top 20 Animal Health Companies Based on 2019 Revenue Read More »

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Shots: The companies will co-develop a first-of-its-kind, single-use flow-through polishing system for GMP operation. The collaboration expected to accelerate affordable access to therapeutics for patients in China and globally The agreement will initially focus on developing and designing the process technologies and automation while later focus on the expanded scope of the process and digital …

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics Read More »

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Shots: Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO Iktos’ …

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design Read More »

Merck paying $2.75B for cancer therapeutics firm VelosBio

The deal will broaden Merck’s oncology portfolio as it picks up an antibody-drug conjugate, a class of biological drugs that target tumor cells even as the pharma giant jettisons other parts of its business

Merck to Acquire VelosBio for $2.75B

Shots: Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020 The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors In Oct’2020, …

Merck to Acquire VelosBio for $2.75B Read More »

PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart …

PharmaShots’ Key Highlights of Third Quarter 2020 Read More »

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or …

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Shots: The approval is based on P-III KEYNOTE-204 study assessing Keytruda (200mg, IV, q3w vs BV (1.8 mg/kg, IV, q3w) in 304 patients in a ratio (1:1) with r/r cHL after at least one multi-agent CT regimen Results: reduction in the risk of disease progression or death by 35%, median PFS (13.2mos. vs 3mos); ORR …

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma Read More »

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Shots: Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program Two P-I studies were completed with M6495 where NCT03224702 in healthy volunteers demonstrated safety and tolerability and reduction of …

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis Read More »

Insights+ Key Biosimilars Events of September 2020

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 alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of September 2020 Read More »

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Shots: The first approval is for certain ESCC patients, which is based on P-III KEYNOTE-181 trial assessing Keytruda vs CT in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10). The study demonstrated mOS (10.3 vs 6.7mos.) Additionally, Keytruda received approval for use at an additional recommended dosage of 400mg, q6w, IV …

Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan Read More »

Merck makes communications leadership change

German pharmaceutical company Merck has appointed Thomas Möller as its new head of group communications. Most recently responsible for corporate communications, Möller has worked at Merck since 2017, when he joined as head of external communications. Prior to that he served as head of media relations at BASF and held various corporate communications positions in …

Merck makes communications leadership change Read More »

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Published: Aug 07, …

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020) 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 »

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease  Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium …

PharmaShots Weekly Snapshot (Jul 27- 31, 2020) 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 »

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis  Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis 2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, …

PharmaShots Weekly Snapshot (Jul 20- 24, 2020) Read More »

MSD’s David Peacock on moving UK healthcare forward

David Peacock has worked across the world for MSD and other companies, and has now taken the helm of MSD’s UK & Ireland operations. In the latest article in our UK Leaders series, he tells us about the opportunities and challenges he is excited to take on in the region. Peacock has had a strikingly …

MSD’s David Peacock on moving UK healthcare forward Read More »

PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid …

PharmaShots Weekly Snapshot (Jul 13- 17, 2020) 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 »