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AstraZeneca (LSE: AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Imfinzi (durvalumab). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. Imfinzi is approved under the FDA's accelerated approval pathway, based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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If there was any doubt that a Republican-led Congress might give a strong boost to federal science spending, the Trump administration probably sealed the deal.

With its call in March for a mammoth $6-billion cut in the annual budget of the National Institutes of Health, the administration appears to have done more than anything else to energize the science community and supportive lawmakers, advocates said.

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The National Institutes of Health will get a $2 billion funding boost over the next five months, under a bipartisan spending deal reached late Sunday night in Congress. The agreement marks a sharp rejection of President Trump’s proposal to cut $1.2 billion from the medical research agency in the current fiscal year.

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For Charles Li, locating his office at the Johns Hopkins University Montgomery County Campus is like coming home.

Li received his MBA from the Carey Business School in 2014 and took the majority of his classes at the Rockville campus. Three years later, when presented with the opportunity to open a business office in Maryland, he chose JHU MCC. He likes the campus library and the proximity to his house.

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Cerecor Inc. (NASDAQ: CERC), a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced topline clinical results from a small, proof-of-concept clinical trial sponsored by the National Institute of Mental Health ("NIMH") of the National Institutes of Health. This was a Phase 2 trial of CERC-501, a potent and selective oral kappa opioid receptor ("KOR") antagonist, in treatment resistant depression ("TRD") conducted under the leadership of Dr. Maurizio Fava of Massachusetts General Hospital ("MGH").

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On Saturday, hundreds of thousands of people are expected to march in Washington, DC, to celebrate and defend science—at a time when many believe that science does, in fact, need defending. President Trump’s budget proposal cuts 31 percent from the Environmental Protection Agency, slashes the Department of Energy’s basic science research program, and zeroes out a program that supports early-stage research into technologies that can reduce our national dependence on fossil fuels. The National Institutes of Health (NIH), which spends $32 billion a year on biomedical research — most of which is undertaken in labs at universities and medical schools across the nation — would see a 20 percent cut, bringing the agency’s budget to its lowest level in 15 years. Beyond science, the president’s proposed budget also eliminates the National Endowment for the Arts and the National Endowment for the Humanities.

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VLP Therapeutics, LLC. (“VLP”), a biotechnology company focusing on the research and development of therapeutic and preventative vaccines and antibody agents, today announced that it successfully received a notice of allowance from the U.S. Patent and Trademark Office for the composition of matter patent to cover immune checkpoint PD-1/PD-L1/PD-L2 inserted alphavirus VLP. The patent will be issued on May 2nd. The patent protects key composition of matter of VLP’s proprietary i-α virus like particles platform technology, and the pharmaceutical composition and vaccine for use in the treatment of cancer. Utilizing the platform technology covered by this patent and other patent estates, VLP is currently focused on developing preventative and therapeutic cancer vaccines as well as next generation of targeted antibody agents.

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Silver Spring-based United Therapeutics Corp. has been clear about its ambitions to build an unlimited supply of certain transplantable organs.

Now, founder Martine Rothblatt said the company's new multiyear collaboration with a 3-D bioprinting company, announced Wednesday, takes it a big step toward that goal.

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RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its licensee for RGN-137, GtreeBNT Co., Ltd., received a positive response from the U.S. FDA for its Phase 3 clinical trial design for RGN-137 to treat epidermolysis bullosa ("EB"). RGN-137 is a dermal wound healing gel that incorporates Thymosin beta 4 ("Tβ4") as the active pharmaceutical ingredient. GtreeBNT is planning to enter into the Phase 3 trial in the U.S. during the third quarter of 2017. 

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PGDx launched in 2010 to bring innovative genetic analyses to cancer researchers, physicians and patients. PGDx uses cutting-edge next-generation sequencing and analysis techniques to identify mutations in patients’ tumors and facilitate the development of personalized treatment plans as well as novel basic science discoveries. In addition, PGDx has developed exciting liquid biopsy technology that uses patient-specific tumor alterations to create a simple blood test that will enable non-invasive tumor detection and monitoring. PGDx is composed of talented individuals with a variety of scientific backgrounds that are dedicated to advancing medicine through genomic technologies.

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When California voters approved US$3 billion in funding for stem-cell research in 2004, biologists flocked to the state, and citizens dreamed of cures for Parkinson’s disease and spinal-cord injuries. Now, the pot of money — one of the biggest state investments in science — is running dry before treatments have emerged, raising questions about whether Californians will pour billions more into stem-cell research.

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The lupus treatment landscape could soon welcome an entrant if a first-in-class anti-interferon monoclonal antibody (mAb) continues to hit clinical-trial targets. AstraZeneca and its biologics R&D branch, MedImmune, are developing anifrolumab, an investigational monoclonal antibody that blocks type 1 interferons to treat moderate to severe systemic lupus erythematosus (SLE).

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The Johns Hopkins University announced today the opening of its state-of-the-art innovation hub, FastForward 1812. The 23,000-square-foot space near Johns Hopkins’ flagship hospital and schools of medicine, public health and nursing provides Baltimore’s burgeoning innovation ecosystem and area startups sought-after office, co-working and wet lab space to accommodate a variety of startups.

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Epigenomics AG (FSE: ECX; OTCQX: EPGNY) (“Epigenomics” or “Company”), Cathay Fortune International Company Limited (“CFIC”) and Blitz F16-83 GmbH (in the future Summit Hero Holding GmbH, “Bidder”), a subsidiary of CFIC, have tonight entered into a business combination agreement (“BCA”) regarding the takeover of Epigenomics by the Bidder. Other than by CFIC, the Bidder will also be indirectly owned by the currently largest shareholder of Epigenomics, Biochain, the strategic partner of Epigenomics and a subsidiary of Team Curis Group.

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AstraZeneca today marks a key milestone in its successful move to Cambridge, UK, with the ‘topping out’ of its new, state-of-the-art, strategic R&D centre and global corporate headquarters at the heart of the Cambridge Biomedical Campus (CBC). The Company, including its biologics research and development arm, MedImmune, already has 2,000 employees actively engaged in the city’s vibrant scientific, academic, clinical and business community. Occupation of the site will begin in stages in 2018.

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BeneVir Biopharm, Inc., a biotechnology company developing oncolytic immunotherapies for the treatment of cancer, announced today that the U.S. Patent and Trademark Office has issued US Patent No. 9,623,059, entitled “Oncolytic Herpes Simplex Virus and Therapeutic Uses Thereof”, covering the composition of matter for Stealth-1H, BeneVir’s lead oncolytic immunotherapy, as well as other platform assets. BeneVir is a portfolio company within Pansend Life Sciences, a subsidiary of HC2 Holdings, Inc. (NYSE MKT: HCHC)

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If you are part of the Maryland entrepreneurial community please take a few minutes to complete our survey.

We are interested in the opinions of people like you regarding TEDCO (Maryland Technology Development Corporation) and its effectiveness in the Maryland Entrepreneurial Ecosystem. By answering the following questions, you will become a valuable part of an important study to evaluate and improve Maryland's position in growing the entrepreneurial technology community within the state.

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Local business leaders, elected officials, scientists and scholars attended the 2017 BioHealth Capital Region Forum at the campus of MedImmune in Gaithersburg on April 19 and 20th. The forum focuses on the biotechnology cluster in Maryland, Virginia, and Washington, D.C., which is working collaboratively to become a top three biotech hub in the United States by 2023.

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EY today announced the finalists for the Entrepreneur Of The Year 2017 Award in the Mid-Atlantic Region. The awards program recognizes entrepreneurs who are excelling in areas such as innovation, financial performance and personal commitment to their businesses and communities. These business leaders were selected by a panel of independent judges. Award winners will be announced at a special gala on June 15, 2017 at The Ritz-Carlton, Tysons Corner.

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Local business leaders, elected officials, scientists and scholars attended the 2017 BioHealth Capital Region Forum at the campus of MedImmune in Gaithersburg on April 19 and 20th. The forum focuses on the biotechnology cluster in Maryland, Virginia, and Washington, D.C., which is working collaboratively to become a top three biotech hub in the United States by 2023.

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The Maryland Life Sciences Advisory Board (LSAB) was created by the legislature in 2007 to assist in maintaining Maryland’s preeminence in the life sciences industry. Comprised of 18 members, the Board includes the Secretary of the Maryland Department of Commerce, a representative designated by the Maryland Technology Development Corporation (TEDCO), and 16 members appointed by the Governor.

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Noble Life Sciences, a full service, GLP (Good Laboratory Practice)-compliant and non-GLP preclinical contract research organization (CRO), today announced that its Board of Directors has appointed Srujana Cherukuri as Chief Executive Officer (CEO) effective immediately. The board also announced that Dr. Cherukuri is now majority owner of Noble Life Sciences. 

"With the acquisition of Spring Valley Laboratories, Noble Life Sciences has grown from a contract research organization offering in vivo drug services in small animals to a full service CRO offering services for the development of drugs, devices, and vaccines in a range of large and small animals," said Ken Carter, Chairman of the Board. "Because the integration of Spring Valley Laboratories is complete, now is the right time to appoint a CEO who will continue Noble’s growth. Dr. Cherukuri was key to the successful integration process, we are enthusiastic about her vision to ensure Noble’s continued growth and future success.”

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Sonavex, Inc., a privately held medical device company dedicated to improving surgical patient outcomes with point-of-care imaging technologies, announced that it received $3 million in recent financing, including the $2.2M first close of its Series A round. The offering, led by Grey Sky Venture Partners, was recently expanded by another $1.3 million following increased demand from investors. Other participating investors include CRCM Venture Capital, TEDCO, the Abell Foundation, medical device executives, surgeons, and successful business executives.

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Apply for up to $3M to support continued development of your Phase II SBIR or STTR-funded heart, lung, blood, or sleep technology requiring approval or clearance by a Federal regulatory agency. The National Heart, Lung, and Blood Institute (NHLBI) SBIR Phase IIB Bridge and Small Market Awards programs aim to de-risk your technology and encourage partnerships between small businesses and investors and strategic partners.

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Portable retinal imager developer Vasoptic Medical raised $1.5 million in a new round of equity financing, according to an SEC filing posted last week.

The Baltimore, Md.-based company is developing a portable retinal imaging device designed to capture physiological information from the retinal microvasculature.

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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the appointment of Tom Polen, 43, as president of BD, effective immediately. In his new role, Mr. Polen will oversee all of BD's operating segments – the Medical and Life Sciences segments, as well as the new Interventional segment, which will include the C. R. Bard, Inc. (NYSE: BCR) businesses following the close of BD's acquisition of Bard, which was also announced today. Mr. Polen, currently executive vice president and president of the BD Medical Segment, will continue to report to Vince Forlenza, who remains chairman and CEO of BD.

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U.S. medical equipment supplier Becton Dickinson and Co will acquire C R Bard Inc, in a $24 billion cash-and-stock deal, adding Bard's devices to its portfolio in the high-growth sectors of oncology and surgery, both companies said on Sunday.

The deal comes two years after Becton Dickinson acquired CareFusion Corp for $12 billion. It is the latest in a string of deals in the medical technology sector, as manufacturers turn to acquisitions to boost profit margins.