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Stockwatch: Limited Acquisition Headroom At Specialty Pharma

Debt-fueled acquisitions helped Teva, Shire and Allergan report well-received fourth-quarter earnings. But sector circumstances have changed since 2016 and the ability to grow by debt-funded acquisition is now severely restricted.

M & A Sales & Earnings Business Strategies

Janssen Strives For Simplicity In HIV R&D, While Hunting For A Cure

HIV may be effectively treated and managed with available therapies, but there is still great unmet need for a functional cure and better prevention to stop the epidemic.

Clinical Trials Infectious Diseases Research and Development Strategies

M&A Analysis Reveals Mid Pharma Purchase Preferences

Immunology- and inflammation-focused biotech companies wondering if a trade exit is in their future will be interested to read that, according to a report from Datamonitor Healthcare, their demographic is the most popular acquisition target of the mid-size pharma cohort.

Commercial Deals M & A

Novo Sees Brighter China Outlook As Volumes Rise

Novo Nordisk says its China business is regaining strength, helped by improved volumes and broad growth in the diabetes sector and despite pricing pressures, and sees a brighter outlook ahead of the local approval of Tresiba.

Commercial Companies China
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Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals Regulation

MEI Pharma Rides Wave Of Interest in AML

MEI Pharma CEO Dan Gold explains Phase III plans for the oral HDAC inhibitor pracinostat in acute myeloid leukemia and why there is still room in the market for a new PI3 kinase inhibitor like MEI-401 in B-cell malignancies in an interview at the Biotech Showcase.

StartUps and SMEs Cancer Research & Development

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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies

NICE Move On Cabometyx Gives BMS Longer To Make Opdivo Case In Second Line RCC

A NICE knock-back for Ipsen's Cabometyx in renal cell carcinoma (RCC) means less pressure on BMS's embattled Opdivo, but not for long if Ipsen is willing to compromise on price, warn analysts.

Reimbursement Commercial

Behind The Blockbuster: Investors Sound Off On Biogen's Future With Spinraza

Entering 2017 with freshly approved Spinraza and new CEO Michel Vounatsos, Biogen still faces challenges and uncertainty. A poll of investors highlights expectations for the company.

Business Strategies Commercial

Safety Is Key As Celgene's Ozanimod Succeeds In First Pivotal MS Test

Celgene's ozanimod successfully cleared its first Phase III hurdle in multiple sclerosis, but safety will be the S1P receptor modulator's differentiating factor in results presented later this year, with additional value coming from ulcerative colitis and Crohn's disease in the coming years.

Research & Development Clinical Trials

Swiss VC Launches New Fund With Orphan Drug Aspirations

Basel-based BioMedPartners has launched a new CHF75m venture capital fund, BioMedInvest III, boosting financing opportunities for startups and mid-sized biotechs in the sparse European market.

Financing Commercial

Shire's Record Year Bolstered By Baxalta, But Shows Across-The-Board Growth

Baxalta's hemophilia franchise immediately becomes Shire's top seller, but the specialty firm enjoyed sales growth across its business areas. Meanwhile, the launch of Xiidra is off to an impressive start in market share and patient access.

Sales & Earnings Companies

Policy & Regulation Explore this Topic

Siliq US Approval Expected To Make Little Dent In Valeant Debt Mountain

A Black Box warning on suicidal ideation and behavior, a REM program and a Medication Guide may hold back the sales growth of Valeant’s new psoriasis therapy in the US, Siliq, following its Feb. 15 approval, although the drug has been associated with high levels of total skin clearance, a finding that could differentiate it from competing products.

Approvals Dermatology Research & Development

Sweeping FDA Changes Could Have “Disastrous Consequences” For Biotech Investment

Lowering the bar on drug approval standards would create a challenging environment for biotech investors, warned Jonathan Leff, a partner at the health care investment firm Deerfield, during the BIO CEO & Investor Conference.

Pricing Debate Medicare

Pharma Earnings Calls Reveal US/EU Trump Divide

Less than a month after his inauguration, President Donald Trump has both unnerved and empowered industry sectors with his immediate actions or divulged potential reforms. Execs offered measured reaction and some speculation during recent earnings calls.

Policy US Election 2016

AbbVie 'Disagrees' With NICE's Draft Rejection Of Venclyxto For CLL

NICE has rejected AbbVie's BCL-2 inhibitor on grounds that evidence presented by the drug maker didn't adequately prove Venclyxto's clinical effectiveness, nor that the cancer product would be value for money.

Health Technology Assessment Market Access

Research & Development Explore this Topic

WORLD Symposium Notebook: New Data In Lysosomal Diseases And A Push For Earlier Testing

The WORLD Symposium Feb. 13 to 16 in San Diego offered everything from basic research through late-stage clinical data in lysosomal diseases, including ArmaGen's blood-brain barrier-crossing treatment for Hurler syndrome and updates from ongoing development programs from rare disease specialists, such as Genzyme, Amicus and Protalix.

Commercial Clinical Trials Innovation

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Melior, Bukwang Seek Diabetes Edge With Novel Insulin Sensitizer

MLR-1023, a repositioned oral compound being developed for type 2 diabetes by Melior and Bukwang, is set to move into Phase IIb in the US and South Korea, and the firms are looking to its novel mechanism of action, improved tolerability and efficacy to carve a niche in a highly competitive sector.

Research & Development Diabetic Care

After APOLLO: Trevena Weighs Commercial Viability Of Opioid Oliceridine

A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.

Clinical Trials Neurology

Novel Antibody Products Ring The Treatment Changes In HIV

Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.

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