Formulation Development
Fortress Biotech Announces Initiation of Phase 2 Clinical Trial of Triplex for Adults Co-Infected With HIV & CMV
Fortress Biotech, Inc. and its partner company, Helocyte, Inc., recently announced a Phase 2 double-blind, randomized, placebo-controlled clinical trial has been initiated to evaluate the…
Alcami Announces the Acquisition of Masy BioServices.
Alcami Corporation recently announced it has completed the acquisition of Masy Systems Inc. (Masy or Masy BioServices), a preferred provider of cGMP Biostorage and pharma support services…..
Aragen Acquires Intox Pvt. Ltd
Aragen Life Sciences recently announced it has signed a definitive agreement to acquire Pune-based Intox Pvt. Ltd. This acquisition will expand Aragen’s end-to-end….
Travere Therapeutics Announces Positive Topline Results From Ongoing Phase 1/2 COMPOSE Study of Pegtibatinase in Classical Homocystinuria
Travere Therapeutics, Inc. recently announced positive topline results from the ongoing Phase 1/2 COMPOSE Study of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated…
Apellis & Sobi Announce EU Approval of Aspaveli (pegcetacoplan) for Treatment of PNH
Apellis Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB recently announced the European Commission (EC) has approved Aspaveli (pegcetacoplan), the first and only targeted C3 therapy, for the treatment of….
BioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients With Alzheimer’s Disease
BioXcel Therapeutics, Inc. recently announced the initiation of its pivotal Phase 3 program for BXCL501, the company’s proprietary, orally dissolving thin film formulation of dexmedetomidine,…
Hearing Loss Company Acousia Therapeutics to Receive CTA for First-in-Man Clinical Study
Acousia Therapeutics GmbH has been granted CTA (Clinical Trial Authorization) by the German BfArM (Federal Institute for Drugs and Medical Devices) for the first-in-man clinical…
Recce Pharmaceuticals Announces Patients to be Dosed in a Phase 1 Intravenous Clinical Trial
Recce Pharmaceuticals Ltd recently announced it has recruited 10 healthy male subjects (first cohort) in its Phase 1 intravenous (IV) clinical trial of its lead…
Forever Healthy & the Buck Institute Announce Partnership to Advance Translational Research in Human Rejuvenation
The Forever Healthy Foundation and the Buck Institute for Research on Aging recently announced a new partnership to advance early stage discoveries at the Institute…
SWK Holdings’ Subsidiary, Enteris BioPharma, Receives $5-Million Milestone Payment From Cara Therapeutics
SWK Holdings Corporation recently announced its wholly owned subsidiary, Enteris BioPharma, received a $5- million milestone payment from Cara Therapeutics related to the license agreement for Peptelligence….
ESCP Models – Hepatitis C Medications (Part 3), Commercial Impact
In this final installment, Josef Bossart, PhD, analyzes annual sales of products in the HCV treatment market and provides a quantitative perspective to the qualitative seesaws of the first two articles…..
SGS Acquires Quay Pharma to Further Strengthen Offering
Quay Pharma, the leading pharmaceutical contract development and manufacturing organization (CDMO), has been acquired by SGS, the Swiss-based world leading….
WACKER & CordenPharma Develop Solutions for Formulating Lipid Nanoparticles, Expanding Their Portfolio for Advanced Medicines
WACKER and CordenPharma have signed a development partnership in the field of Lipid Nanoparticle formulation. The two companies announced they plan to jointly develop know-how…
Immunic, Inc. Publishes Positive Results From the Single & Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
Immunic, Inc. recently announced positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD)…
Immatics & Bristol Myers Squibb Enter Global Exclusive License for TCR Bispecific Program IMA401
Immatics N.V. and Bristol Myers Squibb recently announced they have entered into a license, development, and commercialization agreement for Immatics’ TCR Bispecific candidate, IMA401…..
TheraPanacea & Biogen Announce New Collaboration With the Potential to Advance Digital Health for Personalized Medicine in Neuroscience
Biogen Inc. and TheraPanacea recently announced they have entered into a collaboration focused on multiple therapeutic areas in neuroscience, to further build on the companies’ existing relationship…..
Adagio Therapeutics Reports Reduction in In Vitro Neutralizing Activity of ADG20 Against Omicron SARS-CoV-2 Variant
Adagio Therapeutics, Inc. recently provided an update following external in vitro analyses to evaluate neutralizing activity of ADG20 against the Omicron SARS-CoV-2 variant. The in…
KemPharm Announces Top-Line Results From Clinical Trial Evaluating the Safety & Pharmacokinetics of Higher-Dose SDX
KemPharm, Inc. recently announced top-line results from its clinical trial exploring the safety and pharmacokinetics of serdexmethylphenidate (SDX) delivered at doses higher than those studied…
atai Life Sciences Announces Successful Outcome of Phase 2a Biomarker Trial of RL-007 in Cognitive Impairment Associated With Schizophrenia
atai Life Sciences recently announced positive topline data from its Phase 2a study of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). The 32-patient, single-arm,…
HiberCell to Collaborate With Merck on Phase 2 Clinical Trial of Odetiglucan in Combination With KEYTRUDA in Patients With Metastatic Breast Cancer
HiberCell recently announced a clinical trial collaboration with Merck. This metastatic breast cancer clinical trial evaluates KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with….
