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hamelinclara

Trius: In An About Face, Congress Is Helping Biotech Companies That Are Developing Anti... - 0 views

seekingalpha.com/...hat-are-developing-antibiotics

trius pharma US

shared by hamelinclara on 15 Jan 13 - No Cached
  • The implications for Trius (TSRX) and other leading biotechnology companies involved in antibiotics development are profound.
  • ost large pharmaceutical and biotechnology firms have avoided antibiotics for much of the past two decades in large part due to the intrusion of Congress into the regulatory process
  • The most visible sign of this shift in attitude came from Congress with the passage of the Generating Antibiotics Incentives Now Act or GAIN which became effective on October 1, 2012. This was intended to spur development of new antibiotics through streamlining a regulatory process which has been oppressive for much of the last decade. Responding to the prompting of Congress, I expect the FDA to approach regulatory approval of new antibiotics with the same sense of urgency as drugs for cancer. The end result will be quicker approval of new drugs and new indications for existing antibiotics.
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  • Antibiotics were major drivers of sales growth for the pharmaceutical industry in the 1970s, 1980s and early 1990s which caught the attention of the industry's many critics. A consensus developed among politicians, consumer groups and payors that there was no need for new antibiotics as most bacteria were susceptible to existing products. They saw new antibiotics as offering no advantages over existing drugs even though they were priced many times higher. Faced with this hostile environment, drug companies began to de-emphasize antibiotic research and focus on trendy new areas like depression, cholesterol lowering, gastrointestinal reflux disease, etc.
  • Adding to the move away from antibiotic development was considerable scrutiny about side effects that the industry came under in the early part of the 2000s. A major catalyst for this was the Vioxx side effect issues that caused Merck (MRK) to withdraw this anti-inflammatory drug from the market in 2004
  • ooking beyond the GAIN Act, infectious disease experts, FDA and industry are working on proposals for a new restricted approval pathway that would speed the development of new antibacterial drugs and could address some of the economic disincentives that have driven most pharma companies out of the space. A drug's safety and effectiveness would be studied in substantially smaller, more rapid, and less expensive clinical trials, like those typically used to support Orphan Drug approvals. They would be narrowly indicated for use in small, well-defined populations of patients for whom the drugs' benefits have been shown to outweigh their risks. It would slash the number of patients required to gain approval from about 1,400 for the typical antibiotic indication to 100 or less, cut development time in half, and reduce regulatory uncertainty
hamelinclara

PharmTech Talk » Social Media and the Pharma Industry - 0 views

blog.pharmtech.com/...-media-and-the-pharma-industry

pharma social media

shared by hamelinclara on 17 Jan 13 - No Cached
  • For the pharmaceutical industry, social media poses concerns that range from release of propriety information to regulatory constraints to patient safety. These concerns have limited the industry’s use of a potential marketing and networking tool. Other industries are using Twitter, Facebook, and other social media outlets to promote products, follow consumer trends, and connect directly with their consumers. Is social media being used effectively at all in the pharmaceutical industry? Are there ways social media can be positively used by industry members to share ideas, connect with industry members, or even promote products? And if there is a fear of regulatory infractions, what can or should FDA and other international regulatory agencies do to promote the use of social media?
hamelinclara

Regulatory barriers could restrict potential benefits of m-health in Brazil and Mexico,... - 0 views

www.out-law.com/...in-brazil-and-mexico-says-gsma

bresil mexique regulatory

shared by hamelinclara on 03 Jun 13 - No Cached
  • "The Data Protection Act demands that organisations treat individuals' sensitive personal data with utmost privacy as this data attracts specific protection under the Act, and in addition, patient confidentiality must be maintained at all times," Ross Eckford said. "In effect this means that mobile devices used to store, access or transmit patient data must be secure and not capable of being accessed by unauthorised individuals."
  • "Data transmissions should also be encrypted and secure to prevent data being intercepted, and, in accordance with the Act, the information should only be processed for specified purposes, such as to input data about a patient onto a server containing their medical records or to send a patient a text reminder about hospital appointments," she added.
hamelinclara

The search for blockbuster drugs - McKinsey Quarterly - Health Care - Pharmaceuticals - 1 views

www.mckinseyquarterly.com/rch_for_blockbuster_drugs_1474

blockbuster drugs Pharma

shared by hamelinclara on 09 Jan 13 - No Cached
  • "me-too" compounds,
  • heir efficacy, or comparative effectiveness in treating a specific disease
  • safety, including issues such as side effects and drug interactions
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  • the breadth of their approved uses
  • convenience, including longer-lasting formulas and easier application
  • highly effective,
  • costly and inconclusive.
  • By contrast, many companies have had more success with efforts to improve the safety of products or to get them approved for use in treating additional diseases. Examples are Pfizer's Neurontin, a successful antiepilepsy medication driven predominantly by perceptions of safety differences, and the company's Celebrex, a Cox-2 inhibitor that reduces pain and inflammation and is thought to be easier on the stomach than aspirin. The breadth of approved uses for drugs can also be a significant source of differentiation. We found that nearly two-thirds of those in competitive therapeutic areas, such as depression and allergies, went on to receive regulatory approval for a broader range of treatments after they came on the market (Exhibit 2). Eli Lilly's Prozac, for example, was launched in 1987 to treat depression but has since been approved for use in a range of conditions. Today, drugs entering these competitive areas often need to have a similarly broad range of regulatory endorsements at the time of their launch, thereby raising the bar for compounds in development
  • pharmaceutical companies might rethink their strategies for clinical trials
  • oo many companies commit a disproportionate amount of their time and money to discovering first-in-class compounds when best-in-class opportunities might yield higher returns
  • Second, efficacy shouldn't be pursued at the expense of other sources of differentiation; claims of safety, pharmacokinetics (that is, dosing), and convenience may be as desirable and more clinically attainable
  • one meaningful point of differentiation and scuttle drugs that have even a single subpar attribute.

  • Of the recent blockbusters we analyzed, 59 percent were superior to the competition in only one area, while just 14 percent were superior in two, and no drug was the leader in three or more (Exhibit 3). While some of the remaining 27 percent were distinctive at launch, they are now comparable to their competitors in all significant dimensions but continue to be marketed more effectively. Yet drugs with even a single subpar attribute were generally commercial failures.1

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    These

hamelinclara

Article > Global pharma "in strategic crisis," say companies - 1 views

www.pharmatimes.com/...egic_crisis_say_companies.aspx

pharma stratégies

shared by hamelinclara on 10 Jan 13 - No Cached
  • Three out of four pharmaceutical companies believe their industry is in the midst of a strategic crisis, new research finds. Pricing and cost pressures, regulatory changes and patent expiries are leading to shrinking margins, and the biggest growth opportunities are to be found in the emerging markets, albeit with smaller margins, says the report, from Roland Berger Strategy Consultants.
  • "Pharmaceutical markets such as Europe and the US are stagnating due to rising price pressure, regulatory changes in the healthcare system and more stringent admission requirements, but in emerging markets we are seeing strong growth. Nevertheless, the margins here are lower and driven heavily by non-patent-protected products," says Roland Berger consultant Martin Erharter.
  • R&D costs have risen over 80% worldwide in the past 10 years
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  • number of new product launches has dropped 43%; a
  • eturn on investment (ROI) in R&D is more or less negative
  • new products in emerging markets
hamelinclara

DALLAS, Feb. 8. 2013: Pharmaceutical Market & Biotechnology Industry 2013 Outlook in Ne... - 0 views

www.heraldonline.com/...ical-market-biotechnology.html

biotechnology pharmaceutical

shared by hamelinclara on 13 Feb 13 - No Cached
  • Key Topics Covered Value Based Pricing- Strength of Innovation Vs Fiscal Pressures Major therapy areas to shape up pharma business going forward Europe – Regulatory Pressures and Increasing Pro Generic Stance Will US fall to Pricing Pressures? Emerging Markets and their importance in Growth of Large Cap Pharma Global Pharma -Drugs Losing Patent Protection By 2017 Impact of patent expiry in w.r.t. 2012 total revenue thru 2017 Global Pharma Research Pipeline (PhII And PhIII)- 2013 Global Pharma Milestones in 2013 Roche: Breast Cancer Franchise And Actemra To Drive Near Term Growth, And Multiple Blockbusters In Pipeline To Take Care Of Long Term Growth GlaxoSmithKline: Next Generation Bronchodilators, Melanoma, Hiv And Emerging Market To Lead The Way While Regulatory Overhang In Respiratory And EU Pricing Pressure Persist Bristol-Myers Squibb: Pressures To Dominate In The Near Term, Pipeline Will Take Longer To Deliver AstraZeneca: 2013 Will Be A Transition Year And AZN May Have To Take Some Bold Initiatives Eli Lilly: Late Stage Pipeline Fickle And Risky Merck: News-flow from Mega-trial on MRK's cardiology Franchise would reshape Merck's Growth Prospects Novartis: Back on a Growth Trajectory Novo Nordisk: Hemophilia Franchise and Thrice Weekly Degludec – The Future Drivers Pfizer: M&A Only Can Drive Further Upside In The Near Term Sanofi: Solid Base Business, But Upside From Pipeline Will Take Longer To Come About Global Pharma Sector Industry Tables
  • provides valuations and an in depth analyses of biotech companies, their launched drug portfolio and promising drug candidates in the pipeline.
hamelinclara

Generic companies facing some of the same issues as big pharma (part 1) - Medical Progr... - 0 views

www.medicalprogresstoday.com/...ssues-as-big-pharma-part-1.php

pharma generic Bio

shared by hamelinclara on 15 Jan 13 - No Cached
  • But now the drugs in the headlines are generics. As the industry has grown and matured, it's faced greater scrutiny from regulatory agencies. Now it faces many of the same setbacks that plague their branded brethren.
  • Lipitor, Plavix, Lexapro and Seroquel
  • these same manufacturers are facing a patent cliff of their own
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  • generics have been plagued by high-profile manufacturing and quality issues that have raised questions about the sector's safety and ultimate viability.
  • The market is increasingly complex for generic manufacturers, and business-as-usual isn't going to cut it. In my next post, I'll describe another critical issue facing these drugmakers and their relationship with regulatory agencies: moving into the new space of biologics.
hamelinclara

Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines -- PHILAD... - 1 views

www.prnewswire.com/...f-new-medicines-170329346.html

Pharma Research TransCelerate

shared by hamelinclara on 09 Jan 13 - No Cached
  • Ten leading biopharmaceutical companies announced today that they have formed a non-profit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi launched TransCelerate BioPharma Inc. ("TransCelerate"), the largest ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.
  • financial and other resources, including personnel, to solve industry-wide challenges in a collaborative environment.
  • among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines,
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  • As shared solutions in clinical research and other areas are developed, TransCelerate will involve industry alliances including Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Contract Research Organizations (CROs).
  • "We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.
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