BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

Legislation introduced Tuesday in the Senate seeks to tighten the little-used cost recovery pathway to obtaining Orphan Drug designation in the U.S. The Fairness in Orphan Drug Exclusivity Act is identical to a bill, H.R....
BC Extra | Jan 29, 2020
Politics & Policy

House bill seeks to tweak Orphan Drug Act, could pose threat to pathway

A new bill in the U.S. House of Representatives that seeks to limit abuse of the Orphan Drug Act could have the unintended effect of disincentivizing companies from developing therapies for rare diseases, if the...
BioCentury | Jan 3, 2020
Emerging Company Profile

Click: personalized digital therapeutics for cognitive, neurobehavioral disorders

Click is developing a pipeline of personalized prescription digital therapeutics that could be used alone or in combination with traditional therapeutics to treat cognitive and neurobehavioral disorders. Launched in 2012, Click Therapeutics Inc. markets a...
BC Extra | Nov 27, 2019
Company News

Nov. 27 Company Quick Takes: Orexo, GAIA in second deal for substance abuse digital therapy; plus PDUFA date for Verrica's skin infection candidate and $25M fol

Orexo gets U.S. rights to GAIA's alcohol abuse digital therapeutic  Orexo AB (SSE:ORX) licensed exclusive U.S. rights from GAIA AG to vorvida, a digital therapeutic to treat alcohol use disorder; financial terms are undisclosed. Orexo...
BC Extra | Nov 26, 2019
Politics & Policy

Pioneering FDA commissioner Frank Young dies at 88

Frank Young, who served as FDA Commissioner from 1984 to 1989, a pivotal and tumultuous era in drug regulation, died Nov. 24 at age 88. He was diagnosed last week with B Cell Lymphoma. Former...
BC Extra | Oct 16, 2019
Company News

Pear gearing up to sell products solo as Sandoz backs out of digital deal

While Sandoz has pulled out of its commercialization deal with Pear, the digital therapy pioneer believes it is well positioned to commercialize its flagship digital therapeutics independently. Pear Therapeutics Inc. will assume sole commercial responsibility...
BioCentury | Aug 31, 2019
Product Development

Digital tech meets the patient: first movers are bringing digital to biopharma

At the leading edge of drug development, digital health is starting to make waves, bringing products and tools that offer patients a new level of personalized medicine. At the same time, these technologies give the...
BC Extra | Aug 21, 2019
Company News

Orexo, GAIA to develop digital therapeutic for opioid use disorder

Via a deal with German digital therapeutics company GAIA, Orexo will develop a psychosocial support product intended to enhance the use of Zubsolv buprenorphine/naloxone, its treatment for opioid use disorder (OUD). For its first digital...
BioCentury | Jun 3, 2019
Product Development

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...
BioCentury | Apr 12, 2019
Product Development

Changing models and minds to improve access to addiction treatment

A lack of acknowledgment by key stakeholders in the healthcare system that medications can treat opioid abuse, along with a fragmented reimbursement system, means that effective treatments aren’t getting to the majority of patients who...
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