Sino Biopharmaceutical Limited will pay $110 million up front in addition to a share of profits for Belgian soft mist inhaler developer Softhale. According to New Rhein, the fund's investments to acquire a 60% stake in Softhale were made in 2019 and 2020. Softhale is led by Jan-Torsten Tews, who previously headed respiratory drug groups at Sandoz, Teva, and GSK. … [Read more...] about Sino Biopharm acquires SMI developer Softhale
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Bausch Health gets Canadian rights to Glenmark’s Ryaltris nasal spray
Bausch Health has acquired the rights to commercialize Glenmark’s Ryaltris olopatadine / mometasone furoate nasal spray in Canada, Glenmark has announced. According to Glenmark, which is responsible for regulatory approval under the agreement with Bausch, Health Canada is currently reviewing the company's marketing application for Ryaltris for the treatment of … [Read more...] about Bausch Health gets Canadian rights to Glenmark’s Ryaltris nasal spray
Sandoz acquires rights to Proventil HFA MDI and authorized generic
Sandoz said that the company has acquired distribution rights to the brand and to an authorized generic of Proventil HFA albuterol MDI from Kindeva Drug Delivery and has already launched the generic MDI in the US. Proventil HFA was first marketed in the US by Schering and then by Merck. In April 2019, Par Pharmaceuticals announced that it had launched an … [Read more...] about Sandoz acquires rights to Proventil HFA MDI and authorized generic
Chiesi launches Bronchitol mannitol DPI in the US
Chiesi USA has announced the US launch of Bronchitol dry powder mannitol for the treatment of cystic fibrosis in adult patients. The FDA approved the Bronchitol DPI in November 2020. The company also announced the publication of data from its Phase 3 trial of Bronchitol in the Journal of Cystic Fibrosis. Chiesi also distributes the DPI, which was developed by … [Read more...] about Chiesi launches Bronchitol mannitol DPI in the US
Lonza to dedicate manufacturing suite to Altimmune’s AdCOVID intranasal vaccine
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
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