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Roche Delivers Strong Quarter On Ocrevus Launch, Pipeline Promise

Roche's strong first quarter and promising array of innovative medicines left investors wondering why it didn't also lift its financial guidance for the year.

Sales & Earnings Companies Launches

Bristol's New CSO Lynch Defends Lung Cancer Plans, Proclaims R&D Priorities

Opdivo first-quarter sales were still strong at $1.1bn, largely driven by lung cancer use and helping to drive overall performance, but potential approval of Merck's competing Keytruda with chemotherapy in first-line lung cancer is right around the corner.

ImmunoOncology Cancer BioPharmaceutical

Bayer Ups Guidance While Pharma Head Highlights NHL Drug Copanlisib

Bayer has initiated the regulatory filing process in the US for its pipeline non-Hodgkin's lymphoma drug copanlisib, head of pharma Dieter Weinand said during the company's first quarter earnings call during which the German group also said it was upping guidance for the year.

Business Strategies Cancer Research and Development Strategies

Few Q1 Bright Spots For AstraZeneca Puts Pressure On The Pipeline

AstraZeneca faced commercial challenges in categories like diabetes, cardiovascular disease and respiratory disease during the quarter. FDA action on durvalumab for cancer and benralizumab for asthma are among important milestones ahead.

Sales & Earnings Business Strategies Companies

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AbbVie's Gonzalez Calls Break-Up Proposal Rational, But Premature

CEO says the idea of forming one company around Humira and its earnings and another around the R&D pipeline holds merit but he wants to wait to see the outcome of US tax reform, which could address some of AbbVie's issues.

Sales & Earnings Business Strategies Commercial

ASLAN Firms Up IPO Plans As Lead Asset Progresses

Amid recent progress for its lead molecule, ASLAN has firmed up plans for the timing of its initial public offering, which is now expected to take place in Taiwan mid May with the newly listed shares set to begin trading in early June.

ImmunoOncology Financing Strategy

Latest From Commercial

BioInvent CEO On Pfizer Immunotherapy Alliance

Three years after setting out to turnaround BioInvent, company president & CEO Michael Oredsson explains how the company is developing its immunotherapy offering. With tumor associated myeloid cells, BioInvent secured a deal with Pfizer at the end of 2016, while it intends to go it alone with its regulatory T-cell approach.

ImmunoOncology Deals

Amgen Hit By Enbrel 'Peculiarities' And Repatha Resistance

Amgen reported a surprising double-digit decline for Enbrel during the first quarter and sales for the cholesterol-lowering biologic Repatha showed that the PCSK9 inhibitor is not going to make up for the company's declining revenue any time soon – at least not while payers continue to block its use.

Commercial Sales & Earnings

GSK's Walmsley Focused On Upcoming Launches Amid 'Uncertain' Times

New CEO confirmed GSK's commitment to maintaining its three business unit structure ‒ "as long as all three businesses continue to perform competitively" ‒ as she chaired her first quarterly results presentation at the helm of the big pharma.

Sales & Earnings Companies

Roche Faces Probe On Claims It Derailed Biosimilar Herceptin

Did Roche engage in abusive market conduct aimed at keeping trastuzumab biosimilar versions at bay in India? The Competition Commission of India has sought a detailed investigation into a string of serious allegations brought about by Biocon and Mylan and has held that some of the Swiss firm’s actions prima facie appear to be aimed at adversely affecting the penetration of biosimilars in the country.

Biosimilars Legal Issues

Lilly Shows Diabetes Dominance, But Will It Last?

Lilly's first quarter benefited from rising sales for most of its diabetes products, which has become one of the most difficult therapeutic areas to do business in due to competitive and reimbursement pressures.

Sales & Earnings Market Access

Asia Executives To Watch: Takeda Turns To Local Talent In Changing China

As China moves to implement a raft of planned policy and regulatory changes, including opening up more to new drugs from multinationals, companies including Takeda appear to be ringing in personnel changes and increasingly hiring local executives to senior positions.

Appointments Leadership

Policy & Regulation Explore this Topic

Novartis Slapped With New $49m Fine For Korea ‘Rebates’

Novartis's South Korean subsidiary has been hit with a new fine of around $49m and reimbursement suspensions for a number of its drugs under a new ministerial action related to illegal "rebate" payments made to prescribers.

South Korea Legal Issues Business Strategies

Biogen’s Spinraza Needs Long-Term Confirmatory Data, Says EMA

The EMA may have quickly assessed the US biotech’s antisense spinal muscular atrophy therapy for Europe, but the product’s rapid clinical development means long-term data, and data on its effects in milder disease, or even cures, still need to be collected.

Approvals Rare Diseases

Pfizer Gets First Regulatory Nod For Besponsa

Pfizer's acute lymphocytic leukemia therapy Besponsa has received a positive recommendation in Europe, which should lead to the drug's first approval worldwide and will add to the high expectations for its regulatory outcome in the US later this year.

Approvals Policy & Regulation

Can Cholesterol Drug Sponsors Make The Case For Statin Intolerance?

Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.

Cardiovascular Reimbursement

Research & Development Explore this Topic

Glenmark Readying Xolair Biosimilar Challenge

Glenmark has received US FDA clearance of an IND to start clinical studies with a proposed biosimilar version of Xolair. The Indian company appears confident of addressing any price-related challenges although the targeted launch is still some years away.

Commercial Strategy Biosimilars

Latest From Research & Development

Kiadis Aims To Boost Stem Cell Transplant Market With Adjuvant Filing

Kiadis Pharma hopes to tap into a $1bn-plus commercial opportunity with its lead product ATIR101 in the treatment of blood cancer. ATIR101 has just been filed in Europe on the strength of data from single dose Phase II trial; a Phase III trial to pursue US approval is ongoing.

Cancer Research & Development

Alnylam Plays Up Patisiran As Polyneuropathy Drug Nears Filings

Open-label extension Phase II data with RNAi candidate shows patients with transthyretin-mediated amyloidosis polyneuropathy may be regaining sensation and possibly even regenerating nerves.

Clinical Trials Neurology

DiCE Places Bets On Tomorrow's Small Molecules

Emerging Company Profile: New technology platform aims to apply directed evolution to identify small molecule candidates, much like large molecules like monoclonal antibodies are developed, which the Calif. start-up thinks can bring oral drugs to new fields.

StartUps and SMEs Innovation