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BioWorld - Tuesday, June 16, 2026
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Axis Biotech teams up with Plantform to help developing countries benefit from biologics

Aug. 23, 2017
By Oliver Griffin
BUENOS AIRES, Argentina – Plantpraxis – a melding of Axis Biotech Brasil, of Rio de Janeiro, and Canadian biotech Plantform Corp. – is on track to dent the costs of expensive biologic treatments in developing countries, according to Axis CEO Eduardo Cruz.
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Depression’s pathophysiology is sex-specific, study finds

Aug. 23, 2017
By Anette Breindl
By studying both postmortem brains of depressed humans and animal models of stress-induced depression, researchers have discovered that the gene expression patterns associated with depression are very different in males and females.
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Mylan’s delamanid approved; J&J partners with India’s government to fight TB

Aug. 23, 2017
By T.V. Padma
HYDERABAD, India – India’s drug authority has granted approval to Mylan Inc.’s Indian arm to market its anti-tuberculosis drug delamanid developed specifically for treating multidrug-resistant tuberculosis (MDR TB). Meanwhile, the country is also actively exploring new entities to tackle the TB problem via public-private partnership.
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Off-the-shelf offering: Bid in cell therapy attracts trio, solidarity makes Celularity

Aug. 23, 2017
By Randy Osborne
Celularity Inc. raised “roughly in the $50 million range” by way of its series A round to boost cell and tissue regenerative therapies in cancer and other disorders, said Sorrento Therapeutics Inc. CEO Henry Ji, whose company is one of three involved in what amounts to a new business model. “Basically, the whole cell-therapy division of Celgene is coming back together into Celularity” as the end result, he told BioWorld.
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Astellas Pharma’s acute myeloid leukemia trial doses first patient in new front for broad program

Aug. 23, 2017
By Michael Fitzhugh
A phase III trial testing Astellas Pharma Inc.’s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It’s the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the company establish a basis for a potentially broad label for the orphan-designated medicine.
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Regulatory front

Aug. 22, 2017
The FDA issued a draft guidance on identifying trading partners in accordance with the Drug Supply Chain Security Act (DSCSA).
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In the clinic

Aug. 22, 2017
Matrisys Bioscience Inc., of San Diego, said the first patient was dosed in a phase IIa trial testing a lotion containing Staphylococcus hominis strain A9 as a treatment to decrease or eliminate Staphylococcus aureus on the skin of approximately 50 patients with moderate to severe atopic dermatitis.
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Ethris hooks big pharma partner in five-year mRNA discovery deal

Aug. 22, 2017
By Nuala Moran
LONDON – Ethris GmbH sealed a five-year agreement with Astrazeneca plc and its Medimmune biologics subsidiary for the discovery of messenger RNA (mRNA) therapeutics for treating pulmonary diseases.
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One piece of the FDA's funding is in place, now on to the spending bill

Aug. 22, 2017
By Mari Serebrov
While President Donald Trump's signature on the FDA Reauthorization Act (FDARA) Friday put to rest any lingering fears about potential layoffs at the FDA come Oct. 1, it also paved the way for the next congressional showdown – one that could still shutter parts of the FDA and other federal agencies.
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Saniona partner starts phase III trial of weight loss drug

Aug. 22, 2017
By Michael Fitzhugh
Productos Medix S.A. de C.V., a Mexican weight loss specialist leading the most advanced effort to date to get Danish drug developer Saniona AB's first product to market, started a phase III trial of the drug, tesofensine, in obesity. The Medix-funded study is due to finish within two years and could potentially support approval of the triple monoamine reuptake inhibitor as a monotherapy in Mexico, where it's estimated that more than 70 percent of people are overweight and more than 30 percent are clinically obese.
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