In an expansion of a manufacturing agreement between Altimmune and Lonza that was announced in November 2020, Lonza has agreed to dedicate a manufacturing suite at its Texas facility for production of Altimmune's AdCOVID intranasal vaccine. The FDA cleared Altimmune's IND for a Phase 1 trial of AdCOVID in February 2021. According to Altimmune, AdCOVID a single dose … [Read more...] about Lonza to dedicate manufacturing suite to Altimmune’s AdCOVID intranasal vaccine
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Neurelis raises $114 million for commercialization of Valtoco nasal spray
Neurelis announced that it has raised $114 million in a Series D preferred stock financing to fund commercialization of Valtoco diazepam nasal spray, which was approved by the FDA for the treatment of seizure clusters or acute repetitive seizures in epilepsy patients aged 6 years and older in January 2020. Neurelis launched Valtoco in the US in March 2020. The … [Read more...] about Neurelis raises $114 million for commercialization of Valtoco nasal spray
TFF Pharmaceuticals announces agreements for feasibility studies of mRNA vaccine candidate and aviptadil
TFF Pharmaceuticals has announced agreements for feasibility studies with vaccine developer GreenLight Biosciences and with NeuroRx. TFF is performing studies to determine if dry powder formulations of GreenLight's mRNA COVID-19 vaccine candidate and NeuroRx's Zyesami aviptadil can be successfully created using TFF's thin film freezing technology. According to … [Read more...] about TFF Pharmaceuticals announces agreements for feasibility studies of mRNA vaccine candidate and aviptadil
The Gates Medical Research Institute to develop dry powder lung surfactant for the treatment of RDS in premature infants
The Lundquist Institute for Biomedical Innovation (TLI, formerly LABioMed) has licensed a dry powder synthetic lung surfactant formulation to The Bill & Melinda Gates Medical Research Institute (Gates MRI), TLI said. Gates MRI plans to develop the inhalation powder for the treatment of respiratory distress syndrome (RDS) in premature infants in low- and … [Read more...] about The Gates Medical Research Institute to develop dry powder lung surfactant for the treatment of RDS in premature infants
Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic
The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva Drug Delivery), for patent infringement after Mylan filed an ANDA for a generic version of Symbicort. The judge concluded that "Mylan … [Read more...] about Court rules in favor of AstraZeneca in Symbicort patent dispute, FDA tentatively approves Viatris/Kindeva generic
Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
Pulmatrix has announced plans for clinical development of PUR3100, an iSPERSE dry powder formulation of dihydroergotamine (DHE) for the treatment of migraine, after a PK study in dogs showed exposure kinetics similar to those of the Levadex (MAP0004, Semprana) DHE MDI. The company also provided updates on its development programs for Pulmazole and PUR1800 and said … [Read more...] about Pulmatrix announces development plans for PUR3100 inhaled dry powder DHE for the treatment of migraine
Aridis announces planned clinical development of inhaled mAb cocktail for COVID-19
Aridis Pharmaceuticals announced that it is now receiving preclinical support from the NIAID (National Institute of Allergy and Infectious Diseases) and CoVIC (Coronavirus Immunotherapy Consortium) for a nebulized monoclonal antibody cocktail for COVID-19 and that it plans to initiate a Phase 1/2/3 clinical trial in the second half of this year. The company also said … [Read more...] about Aridis announces planned clinical development of inhaled mAb cocktail for COVID-19
Ryaltris nasal spray approved by Russian Ministry of Health
Glenmark Pharmaceuticals announced that the Ministry of Health of the Russian Federation has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis, and the company expects to launch the nasal spray in Russia in the first quarter of fiscal year 2021-22. Glenmark Pharmaceuticals Senior … [Read more...] about Ryaltris nasal spray approved by Russian Ministry of Health
Microbion gets additional funding from CFF for inhaled pravibismane
According to Microbion Corporation, the company has received up to $1.8 million from the Cystic Fibrosis Foundation to fund toxicology studies to support an IND for the company's pravibismane inhalation suspension for the treatment of lung infections in CF patients. CFF had previously provided a grant worth up to $5.6 million for development of the inhaled … [Read more...] about Microbion gets additional funding from CFF for inhaled pravibismane
Seelos repurchases royalties on any future sales of SLS-002 intranasal racemic ketamine
Seelos Therapeuticse has announced an additional amendment to its 2018 agreement with Vyera Pharmaceuticals (now Phoenixus) in order for the company to repurchase 9% of royalties payable on any future net sales of SLS-002 intranasal racemic ketamine. A previous amendment to the agreement that allowed Seelos to make cash and stock payments instead of a milestone … [Read more...] about Seelos repurchases royalties on any future sales of SLS-002 intranasal racemic ketamine