Major Events in the Pharmaceutical Industry! (Feb. 2020)

1. Gilead: U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

2. Gilead Sciences Initiates Two Phase 3 Studies of Investigational Antiviral Remdesivir for the Treatment of COVID-19

3. Clover and GSK announce research collaboration to evaluate coronavirus (COVID-19) vaccine candidate with pandemic adjuvant system

4. Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine

5. CEPI and GSK announce collaboration to strengthen the global effort to develop a vaccine for the 2019-nCoV virus

6. Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

7. Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments

8. AstraZeneca divests global rights to Movantik: AstraZeneca has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma

9. AstraZeneca completes divestment agreement with Atnahs Pharma for established hypertension medicines

10. Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

11. Sanofi to create new industry leading European company to provide active pharmaceutical ingredients (API*)

12. Regeneron: EYLEA® (aflibercept) Injection Reduced Risk of Developing Vision-Threatening Events by 75% After Two Years in Patients with Diabetic Retinopathy

13. Merck Receives Approval for BELSOMRA® (suvorexant) C-IV Label Update to Include Findings from Study of Insomnia in Patients with Mild-to-Moderate Alzheimer’s Disease

14. Merck: FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

15. Merck to Focus on Key Growth Pillars Through Spinoff of Women’s Health, Trusted Legacy Brands and Biosimilars Products into New Company (“NewCo”)

16. Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

17. Merck: ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

18. Merck Receives Complete Response Letter from the US FDA for Supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule

19. Roche’s risdiplam showed significant improvement in motor function in people aged 2-25 with type 2 or 3 spinal muscular atrophy

20. Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer’s disease

21. China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

22. FDA grants priority review to Roche’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer

23. FDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer

24. Pfizer: XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC

25. Pfizer: European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

26. Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

27. Novartis receives EC Approval for Beovu®, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

28. Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

29. Novartis and DNDi to collaborate on the development of a new oral drug to treat visceral leishmaniasis

30. Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer

31. Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

32. Alcon to Launch Pataday, the Eye Allergy Drop with the #1 Doctor-Prescribed Active Ingredient, following FDA Approval of OTC Switch

33. Bayer announces Phase III trials with new aflibercept 8mg formulation

34. Bayer and Nuvisan create new research unit in Berlin

35. Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

36. Johnson & Johnson Launches Heartline™, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke

37. Janssen: New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

38. BioMotiv and Bristol-Myers Squibb announce the Launch of Anteros Pharmaceuticals

39. U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

40. BMS: Opdivo (nivolumab) Plus Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 42-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

41. BMS: Updated CheckMate -025 Results Show 26% of Patients Treated with Opdivo are Alive at Five Years in Patients with Previously Treated Advanced or Metastatic Renal Cell Carcinoma

42. BMS: Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer

43. Amgen, Cytokinetics And Servier Announce Continuation Of GALACTIC-HF Following Planned Interim Analysis

44. Biogen and Sangamo Announce Global Collaboration to Develop Gene Regulation Therapies for Alzheimer’s, Parkinson’s, Neuromuscular, and Other Neurological Diseases

45. Lilly Announces Topline Results for Solanezumab from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study

46. Lilly Completes Acquisition of Dermira

47. Lilly: Trulicity® (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease

48. FDA Advisory Committee Votes in Favor of Lilly's CYRAMZA® (ramucirumab) as First-Line Treatment for Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

49. Abbott announces first-of-its-kind trial to assess new therapy option for people at risk of stroke

50. Abbott's in-development fully implantable heart pump system earns FDA's breakthrough device designation

51. Abbott introduces next-generation heart rhythm management devices in Europe, featuring state-of-the-art patient app and bluetooth connectivity

52. Abbott and Insulet partner to integrate next-generation glucose sensing and automated insulin delivery technologies for seamless diabetes care

53. New real-world data show that Abbott's freestyle Libre system delivers positive health outcomes for people with type 1 and type 2 diabetes

54. GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma

55. FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States

56. U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

57. European Medicines Agency accepts submission of GSK’s Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

58. GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma

59. First-of-its-kind global collaboration (Evotec, GSK, Johnson & Johnson, Otsuka Pharmaceutical Co., Ltd., based in Japan, the Bill & Melinda Gates Medical Research Institute and the Bill & Melinda Gates Foundation) launched to develop transformative treatment regimens for tuberculosis

60. Boehringer Ingelheim receives approval for Aservo® EquiHaler®, industry first equine asthma therapy

61. Boehringer Ingelheim: CARMELINA® subgroup analysis supports long-term cardiovascular and renal safety of linagliptin in older people with type 2 diabetes

62. Boehringer Ingelheim Enters Discovery Stage Collaboration with Trutino Biosciences to Grow Its Cancer Immunology Portfolio with Novel Cytokine Platform

63. Boehringer Ingelheim receives positive CHMP opinion for nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease

64. AbbVie: RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

65. AbbVie Provides Update from Phase 3 Study Evaluating VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine in Newly-Diagnosed Patients with Acute Myeloid Leukemia (AML): Study did not demonstrate statistically significant improvement in the primary endpoint of overall survival (OS)

66. Novo Nordisk invests DKK 800 million in upgrading and expanding production facilities in Kalundborg

67. Takeda Issues US Recall of Two Lots of VONVENDI

68. Exelixis Announces Encouraging Results for Cabozantinib in Combination With Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

69. Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer

70. Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder

71. Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome Did Not Meet the Primary Endpoint

72. Teva Announces Positive Top-Line Results from AJOVY® (fremanezumab) Clinical Trials in Japan

73. Eisai and FUJI YAKUHIN Conclude License Agreement Concerning the Development and Distribution of Dotinurad, a Treatment for Hyperuricemia and Gout, in China

74. Daiichi Sankyo: Anti-epilepsy Drug VIMPAT ®, Submission for Supplemental Application for Approval in Japan

75. PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer

76. CSL Behring: PRIVIGEN® (Immune Globulin Intravenous (Human), 10% Liquid) Granted Orphan-Drug Designation for the Investigational Treatment of Systemic Sclerosis (SSc)

77. University City Science Center partnership with CSL Behring accelerates the search for new biotherapies at the University of Pittsburgh and the University of Delaware

78. BioMarin's Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA

79. Ionis treatment for Alexander disease granted orphan drug status from EMA

80. Myriad Submits sPMA for myChoice® CDx with Lynparza® in First-Line Maintenance Therapy in Advanced Ovarian Cancer

81. Myriad: New Study Demonstrates the Ability of Prolaris® to Predict Which Men With Prostate Cancer Will Benefit from Multi-Modality Therapy

82. PerkinElmer Collaborates with Public Health England on SCID Screening Evaluation Initiative

83. Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin- EJFV) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

84. Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

85. Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

86. Shionogi’s FETROJA® (cefiderocol) Now Available for the Treatment of Complicated Urinary Tract Infections in the U.S.

87. Shionogi receives positive CHMP opinion for fetcroja® (cefiderocol) for the treatment of infections due to aerobic gram-negative bacteria in adult patients with limited treatment options

88. Alnylam Completes Enrollment of HELIOS-A Phase 3 Study of Vutrisiran for the Treatment of hATTR Amyloidosis with Polyneuropathy

89. Alnylam Announces Approval in Brazil of ONPATTRO® for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy

90. Collegium to Acquire U.S. Rights to Nucynta Franchise

91. Vertex Announces Availability of Cystic Fibrosis Medicine KALYDECO® (ivacaftor) in New Zealand

92. Varian Receives FDA 510(k) Clearance for Ethos Therapy

93. Merck KGaA, Darmstadt, Germany, Divests Allergopharma to Dermapharm Holding SE

94. Sun Pharma Introduces ABSORICA LD™ Capsules for Management of Severe Recalcitrant Nodular Acne in the U.S.

95. Sun Pharma Launches RIOMET ER Oral Suspension in the US

96. Chugai Pharma: Polatuzumab Vedotin Achieved Primary Endpoint in the Japanese Phase II study for Relapsed or Refractory Diffuse Large B-cell Lymphoma

97. Foundation Medicine and Chugai Announce Partnership with National Cancer Center for the Use of FoundationOne® Liquid in the Third Stage of SCRUM-Japan

98. Chugai Files for Additional Indications of Tecentriq and Avastin for the Treatment of Unresectable Hepatocellular Carcinoma

99. Chugai Receives Orphan Drug Designation for RG6042 in Huntington's Disease from the MHLW

100. Results of Phase II Study with Chugai’s Nemolizumab for Prurigo Nodularis Published in the New England Journal of Medicine Online

101. Chugai Pharma: Anti-CD20 Monoclonal Antibody “Rituxan®,” Approved for Additional Indication of Acquired Thrombotic Thrombocytopenic Purpura

102. Chugai Obtains Approval for Additional Indication of Rozlytrek for ROS1 Fusion-Positive Non-Small Cell Lung Cancer

103. Chugai Obtains Approval for Additional Indication of Alecensa for Recurrent or Refractory ALK Fusion Gene-Positive Anaplastic Large Cell Lymphoma

104. FDA approves Lundbeck’s Vyepti™ (eptinezumab-jjmr) – the first and only intravenous preventive treatment for migraine

105. FDA Grants Premarket Clearance of Asuragen’s AmplideX® Fragile X Dx and Carrier Screen Kit

106. Five Prime Therapeutics Licenses Antibodies to Seattle Genetics for Use in Novel Antibody Drug Conjugate (ADC) Programs

107. Five Prime Therapeutics Provides Update on Phase 2 Trial of Cabiralizumab Combined with Opdivo® in Pancreatic Cancer: Phase 2 Trial of Cabiralizumab plus Opdivo (nivolumab) with and without Chemotherapy in Advanced Pancreatic Cancer Did not Meet Primary Endpoint

108. Catalent Completes Acquisition of Leading Cell Therapy Company MaSTherCell Global

109. Catalent and Zumutor Biologics Collaborate to Manufacture First-in-Class mAb to Treat Solid Tumors

110. Perrigo and Catalent Announce FDA Approval of Perrigo’s AB-rated Generic Version of ProAir® HFA

111. NantOmics and NantHealth Announce Results of Proprietary Machine Vision AI Software Study Demonstrating the Ability to Identify Aggressive Subtypes of Breast Cancer from Digital Pathology Images

112. Insmed Announces Positive Top-Line Results from Phase 2 WILLOW Study of INS1007 in Patients with Non-Cystic Fibrosis Bronchiectasis

113. Baxter Completes Acquisition of Seprafilm Adhesion Barrier

114. Genmab: U.S. FDA Filing Acceptance and Priority Review for sBLA, Submitted by Novartis, for Ofatumumab in Relapsing Multiple Sclerosis

115. Immatics and GSK Partner to Develop Novel Adoptive Cell Therapies

116. Namocell, Takara Bio USA and HepaTx collaborate on single cell genomics analysis for cell therapy to treat late-stage liver diseases

117. CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia

118. Pharmacosmos establishes new specialty pharmaceutical company pharmacosmos therapeutics, Inc. in the US

119. GRAIL Initiates First Interventional Study Using its Multi-Cancer Early Detection Test to Guide Clinical Care

120. PTC Therapeutics Announces First Publication of Real-World Data Showing TranslarnaTM (ataluren) Significantly Preserves Ability to Walk for Longer in Children with Duchenne Muscular Dystrophy

121. NS Pharma: NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)                       

122. PTC Therapeutics: SUNFISH Pivotal Results for Risdiplam (RG7916) Demonstrate Medically Meaningful Benefit in Broadest Age Group of Patients Studied with Type 2 and 3 Spinal Muscular Atrophy

123. Assertio Therapeutics Announces Closing of Sale of NUCYNTA® Franchise to Collegium Pharmaceutical for $375.0 Million

124. Synteract Expands into Asia Pacific and South Africa Through Acquisition of Specialty Biometrics CRO

125. Brickell Biotech Announces Publication of its U.S. Phase 2b Study Results for Sofpironium Bromide in Patients with Primary Axillary Hyperhidrosis in the Journal of the American Academy of Dermatology

126. Halozyme Announces FDA Has Accepted Biologics License Application For Fixed-Dose Subcutaneous Combination Of Perjeta® And Herceptin® Using Enhanze® Technology

127. Revance Announces U.S. FDA Acceptance of Biologics License Application (BLA) for DAXI to Treat Glabellar (Frown) Lines

128. Ambry Genetics: First Prospective Study Shows +RNAinsight™ Identifies More Patients with Increased Risk for Hereditary Cancer Than DNA-Only Testing

129. Valeritas Announces Agreement for Zealand Pharma to Acquire Business and Retain Employees

130. FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks

131. Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules

132. Advaxis Announces Positive Clinical Data in Ongoing Phase 1/2 ADXS-503 Trial in NSCLC at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting

133. Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium

134. Advaxis and Personalis Announce Research Agreement to Deploy ImmunoID NeXT Platform in the ADXS-503 Clinical Program

135. Sinclair Pharma Announces transfer of Distribution Rights for Sculptra® in Western Europe to Galderma

136. Acer Therapeutics Announces ACER-001 for Urea Cycle Disorders Trial Shows Bioequivalence to BUPHENYL®

137. Aimmune Licenses Exclusive Worldwide Rights to Xencor’s XmAb®7195 for the Development of Next-Generation Food Allergy Treatments

138. Ironwood Pharmaceuticals Announces Publication of Positive IW-3718 Phase IIb Data in Gastroenterology

139. Biodesix Announces Initiation of Clinical Phase Biomarker Development Program with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

140. FORMA Therapeutics Announces FT-4202 Granted Fast Track Designation And Rare Pediatric Disease Designation For Treatment Of Sickle Cell Disease

141. Adamas Announces Publication of the Two-Year Phase 3 Open-Label EASE LID 2 Trial of GOCOVRI® for Dyskinesia in Patients with Parkinson’s Disease

142. Regulus Therapeutics Reinitiates Multiple Ascending Dose Study of RGLS4326 for the Treatment of ADPKD

143. Clovis Oncology Announces Availability and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in France

144. Puma Biotechnology Receives U.S. FDA Approval of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

145. AGTC Announces Completion of Enrollment in the Two Highest Dose Groups of its Ongoing Phase 1/2 Clinical Trial in Patients with X-Linked Retinitis Pigmentosa

146. GW Pharmaceuticals and Greenwich Biosciences Submit Supplemental New Drug Application to U.S. FDA for Epidiolex® (cannabidiol) for the Treatment of Tuberous Sclerosis Complex

147. EUSA Pharma: Sylvant® (siltuximab) recommended by the national comprehensive cancer network® (NCCN®) guidelines as a preferred treatment option for patients with idiopathic multicentric castleman disease (IMCD) for patients with plasmacytic or mixed histology

148. Biohaven's Troriluzole Study For Generalized Anxiety Disorder (GAD) Misses Primary Endpoint

149. Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults

150. Mapkure, Beigene and Springworks announce initiation of phase 1 clinical trial of bgb-3245, a selective next-generation B-Raf inhibitor, in adult patients with advanced or refractory solid tumors

151. FDA clears Fresenius Medical Care’s Novalung for treatment of acute respiratory and cardiopulmonary failure

152. Kiadis Pharma announces FDA clearance of clinical study by The Ohio State University in R/R AML with off-the-shelf NK cells from universal donors

153. Cosmo announces that Acacia Pharma Group plc obtains U.S. FDA Approval of BARHEMSYS®

154. Cosmo announces Australian regulatory approval of GI GENIUS™

155. Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML

156. Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

157. Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

158. Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients

159. NS Pharma: Nippon Shinyaku signs a new co-promotion agreement with Janssen Pharmaceutical K.K. for ZYTIGA® in Japan      

Sonali Pandhe Ph.D. is an AMAG Pharmaceuticals employee. All the views and perspectives are fully independent. They do not represent any views of AMAG Pharmaceuticals, or any other company. The information compiled in this post is publicly available. Thank you!