Small Molecules

12 Sep 2018 Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial
10 Sep 2018 Cyclacel Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Sapacitabine With Olaparib in BRCA Mutant Breast Cancer
10 Sep 2018 Amryt receives IND approval from FDA for AP101 enabling the opening of US clinical trial sites
08 Sep 2018 European Commission Expands Labelling for Janssen’s INVOKANA® and VOKANAMET® to Include Positive Data on Cardiovascular Outcomes
08 Sep 2018 Oryzon receives approval to begin REIMAGINE: a Phase IIa clinical trial with Vafidemstat (ORY-2001) in aggressiveness
08 Sep 2018 Pfizer Receives Breakthrough Therapy Designation from FDA for PF-06651600, an oral JAK3 Inhibitor, for the Treatment of Patients with Alopecia Areata
07 Sep 2018 ITF Pharma Announces FDA Approval Of TIGLUTIK™ (Riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS)
06 Sep 2018 Advicenne Announces FDA Clearance of IND to Commence Pivotal Phase 3 Trial of ADV7103 for Distal Renal Tubular Acidosis
06 Sep 2018 Vertex Completes Enrollment of Two Phase 3 Studies of VX-659 in Triple Combination with Tezacaftor and Ivacaftor for the Treatment of Cystic Fibrosis
06 Sep 2018 Neumentum Announces Dosing of Patients in Phase I Study Evaluating Its Lead Product Candidate, NTM-001, a Non-Opioid in Development for the Management of Moderately Severe Acute Pain
06 Sep 2018 Lilly Announces Positive Phase 3 Results in Study of Flortaucipir PET Imaging Agent
06 Sep 2018 Gilead and Galapagos announce TORTUGA phase 2 study of filgotinib in ankylosing spondylitis achieves primary endpoint
06 Sep 2018 Xenon Expands Ion Channel Neurology Pipeline with Addition of XEN496, a “Phase 3 Ready” Potassium Channel Modulator for the Treatment of Epilepsy
06 Sep 2018 Checkpoint Therapeutics Announces Encouraging Safety and Efficacy Data from Phase 1/2 Clinical Trial of EGFR Inhibitor CK-101
05 Sep 2018 Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292
05 Sep 2018 Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
04 Sep 2018 Abivax reports impressive results in clinical phase 2a trial of ABX464 as an oral treatment for ulcerative colitis patients
04 Sep 2018 European Commission Grants Marketing Authorisation for Puma Biotechnology’s NERLYNX® (neratinib) for Extended Adjuvant Treatment of Hormone Receptor Positive HER2-Positive Early Stage Breast Cancer
04 Sep 2018 Addex’s Selective mGlu2 PAM ADX71149 Shows Promise in Treating Severe Panic Disorders and PTSD
04 Sep 2018 BioCryst Reports Positive Results Across Multiple Endpoints in ZENITH-1 Trial of Oral BCX7353 as Acute Therapy for Hereditary Angioedema (HAE) Attacks
04 Sep 2018 Biogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV Glibenclamide) for Large Hemispheric Infarction
31 Aug 2018 FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
31 Aug 2018 FDA Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients
30 Aug 2018 Actelion Submits Application to EMA Seeking Approval of OPSUMIT® (macitentan) for the Treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
30 Aug 2018 Arena Pharmaceuticals Presented Phase 1 Clinical Data for Ralinepag in Pulmonary Arterial Hypertension at the European Society of Cardiology

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