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Intercept Says Data Indicate Pruritus Worries In NASH Could Be Overstated

Patient-reported outcomes indicate patients don’t see itch as a major quality-of-life factor. Intercept also reports that adding earlier-stage patients to review of OCA shows better data on resolving NASH.

Clinical Trials Safety Liver & Hepatic

Ambitious AB Science Gets Masitinib Win For Severe Asthma

Plagued by concerns on the integrity of data and compliance issues with its clinical practices, the French firm still believes masitinib could be effective for ALS, multiple sclerosis, cancers, asthma and even Alzheimer's.
Strategy Clinical Trials Respiratory

Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval

Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.

Business Strategies Clinical Trials Research & Development

Spotlight On APAC

Big Pharma Advances Efforts In TB But Pricing Stays Key Concern

Price cuts, new treatments for TB and alliances to improve access to these medicines were among the key talking points at the recently concluded Union World Conference on Lung Health in India. TB survivors and activists were also vocal and pressed hard for their demands to be heard.

Infectious Diseases Commercial


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Lupin Offloads Kyowa Pharma To Unison for $525m But Not Exiting Japan

Lupin plans to invest in acquisitions and organic growth in the US and India after selling Japanese subsidiary Kyowa Pharma for an enterprise value of around $525m to Japan private equity group Unison Capital. But the Indian firm stresses it is not exiting Japan and will continue to look for marketing partnerships.

Deals India

Lupin Q2 Hit By US Settlement, Japan Injectables Selloff

Despite 10% revenue growth, Lupin ends up with a second-quarter loss from a one-time charge from settling a US lawsuit and the sale of its Japan injectables business. It's now counting on levothyroxine and secnidazole to carry it through the next few quarters, amid speculation that it might divest its Japanese subsidiary. 

Commercial Sales & Earnings

Sun Upbeat On IL-23 Prospects In US, Ilumya Faring ‘Reasonably’

Sun expects interleukin-23-targeting drugs to stay a preferred treatment option for psoriasis in the US and saw some sales uptick for its Ilumya in that market in Q2, although it isn’t keen on an auto injector option. Management was also upbeat on prospects in China and Japan.

Commercial Sales & Earnings

Finance Watch: Cell And Gene Therapies Buck 2019’s Venture Capital Trend

Private Company Edition: VC deals are surging this year for cell and gene therapy firms, according to ARM’s third quarter report. Also, Vivo Capital and the CF Foundation plan to invest nearly $2bn in health care and life science opportunities, and Akeso completes $150m series D.

Financing Regenerative Medicine

Venture Funding Deals: Tenaya's $92m, Nuvation's $275m Lead October Rounds

Former Medivation CEO David Hung launched stealthy oncology start-up Nuvation with $275m in series A venture capital, while Tenaya's series B brought in $92m for small molecules as well as cell and gene therapies to treat cardiovascular diseases.

Deals Financing

Momentum Back At Cipla In Q2 But Albuterol Delayed In US

Cipla had a strong run across key businesses in Q2, with products like generic Sensipar retaining share in the US despite stiff competition. But launch timelines for generic albuterol in the US have been pushed back to fiscal 2021.

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Policy & Regulation Explore this Topic

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GW Gets Two Cannabis-Based Meds Backed By NICE

Two cannabis-based drugs developed by GW Pharmaceuticals have been approved for use on the NHS in England for the first time and will be prescribed to patients with epilepsy and multiple sclerosis.
Neurology Health Technology Assessment

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Intellectual Property Infectious Diseases

Mehta Analysis: Who Will Speak Out As Regulators Are Politicized?

In his latest opinion piece, Viren Mehta fears the impact that ideologically motivated and protectionist actions around the world will have on the biopharma sector and ultimately on patients.

Regulation Trade
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Research & Development Explore this Topic

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Gilead Moves On From Selonsertib, Looks To ATLAS To Map Its NASH Future

Gilead detailed its Phase III failure with ASK1 inhibitor selonsertib in NASH, but anticipates finding a new regimen to take into Phase III in NASH with the ATLAS combination study data expected in December.

Clinical Trials Business Strategies

Allena Bets On Its Kidney Stone Treatment Despite Placebo Concerns

Execs are hoping having positive results in two studies will help raise funds for continued development. But high placebo results have caused concern for investors.
Clinical Trials Renal

ASLAN Falls As TreeTopp BTC Study Fails

ASLAN’s pivotal Phase II TreeTopp study of varlitinib in biliary tract cancer missed its co-primary endpoints of progression-free survival and overall response rate.

Cancer Clinical Trials
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