May 17, 2018
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New Haven Architects’ Design One of Six Selected for review for uberAIR…

NEW HAVEN, LOS ANGELES: New Haven based Pickard Chilton working with Arup, Corgan, and The Beck Group was selected as one of six leading architecture and engineering firms to showcase the first designs at Uber’s 2nd Elevate…
May 18, 2018
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Connecticut Job Loss Two Months In A Row, Growth Lags Region and US

HARTFORD: The Connecticut Labor Department reported another loss in jobs by the state even as the US economy added more than 168,000 jobs in April. The loss of 1,400 jobs follows a loss of 3500 jobs in March, which was…
May 17, 2018
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New Haven Biotech Spends Big To Advance Clinical and Commercial Programs

NEW HAVEN: Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), the clinical stage biopharmaceutical company headquartered in downtown has reported its first quarter results financial and clinical results. Vlad Coric,…
May 18, 2018
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Single-Family Home and Condo Prices Continue Upward Climb

BOSTON: median single-family home price in Connecticut increased in March and the median condominium price followed a similar trajectory, according to the latest report from The Warren Group, publisher of The Commercial…

Water Company Stockholders To Be Urged To Weigh in On Buyout

May 03, 2018
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Everource'Judge, wants Connecticut Water. Asking stockholders to weigh in. California Water's Kropelnicki say's his deal is…

Biotech Raises $2.5 To Advance Innovation in Skin Care and The ”Human Microbiome”

May 08, 2018
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FARMINGTON: Azitra Inc. a research stage biotech has raised $2.15 million in convertible debt financing to support…

US Government Funded Organization Brings Up to $6.5 Million to New Haven Biotech

May 08, 2018
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Melinta Gets Investment To Fight "Superbugs" - See Report NEW HAVEN: Melinta Therapeutics, Inc. [Nasdq:MLNT], a…

CT Attorney General, Business Can Hold Meetings With Employees

Apr 27, 2018
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HARTFORD: Connecticut Attorney General, George Jepsen has again issued an opinion on the attempts by state legistlators to…

Former Alexion Executives Raise $37 Million For New Rare Disease Company

Apr 27, 2018
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Fryer, Mackay, Fryer, all former Alexion executives FARMINGTON: Rallybio, LLC, was established to identify and accelerate…

Alexion Stock "Rockets" on Profits and Trial Results

Apr 27, 2018
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By Mitchell Young NEW HAVEN: Alexion Pharmaceuticals Inc. [Nasdaq: Alxn] stock has finally broken out of its doldrums driven…

Water War About To Pour Down In Connecticut

Apr 20, 2018
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HARTFORD: Eversource Energy, New England’s largest public utility company made an offer on April 5th to purchase the…

Alexion Acquisition - A Pick for the Long Haul

Apr 20, 2018
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By Mitchell Young NEW HAVEN: Alexion Pharmaceuticals, Inc. [NASDAQ:ALXN] is acquiring Wilson Therapeutics AB (publ) for $855…

Connecticut Innovations Funds 43 Companies in Final 2017 Quarter

Apr 18, 2018
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ROCKY HILL: Connecticut Innovations (CI), Connecticut’s venture capital arm and what they say is the “leading source of…

Health

Quinnipiac Appoints Dean of Nursing School

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NORTH HAVEN : Lisa G. O’Connor of East Haddam has been appointed Dean, of the School of Nursing at Quinnipiac University, O’Connor had been associate…

Hartford HealthCare To Acquire Bridgeport’s St. Vincent's Medical Center

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BRIDGEPORT: St. Vincent’s Medical Center in Bridgeport and its parent Ascension Health have signed a non-binding letter of intent with Hartford…

Anti-Marijuana Organization Cites Potential Costs to Legalization

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HARTFORD: While Advocates for legalization of recreational use of Marijuana in Connecticut cite economic benefit to the state an anti-legalization…

Advocates for marijuana sales point to big economic boost

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By: Keith M. Phaneuf |ctmirror.org Advocates for legalizing recreational marijuana use in Connecticut — and taxing its sales — are hoping a holistic,…

Breaking down this year’s Access Health CT open enrollment

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By: MACKENZIE RIGG | ctmirror.org In all, 114,134 residents enrolled in private health insurance through the state’s health insurance exchange,…

Wallingford Medical Device Company Launches Product To Control Internal…

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WALINGFORD: Z-Medica, LLC, a developer of hemostatic devices, announced that QuikClot Control+® approved by the FDA in June of 2017 is now…

Children's Hospital Invests In Mass. Biotech

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HARTFORD: Connecticut Children's Medical Center has made an investment in a small Massachusetts based biotech company Biostage, Inc. [OTCQB:…

State Seeks More Medical Marijuana Sellers

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HARTFORD: US Attorney General Jeff Sessions may be trying to arrest the increase in marijuana sales in states across the country, but Connecticut is…

Chester Retirement Community Sold

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CHESTER: Chester Village West set on 55 acres with 105 cottages and apartments was purchased by Masonicare, based in Wallingford, the state’s largest…

ACA Mandate Gone, State Eyes Imposing Its Own

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By: Ana Radelat | ctmirror.com Washington – As Congress is about to vote on a tax overhaul that will gut the Affordable Care Act’s mandate that most…

Technology

Legacy AV Company Shows Its Stuff With New Headquarters

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NORTH HAVEN: HB Communications, founded in 1946 is an audiovisual communication solutions company, has opened the doors to its newly renovated…

Tech Firm Relocates To Shelton Office Building

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SHELTON, Dark Field Technologies has relocated their headquarters from Orange to Shelton, according to Jon Angel, president of Angel Commercial,…

New Haven Architects’ Design One of Six Selected for review for uberAIR…

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NEW HAVEN, LOS ANGELES: New Haven based Pickard Chilton working with Arup, Corgan, and The Beck Group was selected as one of six leading architecture…

Connecticut Innovations Funds 43 Companies in Final 2017 Quarter

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ROCKY HILL: Connecticut Innovations (CI), Connecticut’s venture capital arm and what they say is the “leading source of financing and ongoing support…

Fox Network Prevails Against Fairfield Video Search Company In Court

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FAIRFIELD: TVEyes, Inc. has lost in the United States Court of Appeals for the Second Circuit to Fox News Network, LLC, a decision preventing the…

OPINION: How Connecticut became the least likely innovation hub in the U.S.

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By Matthew McCooe, Connecticut Innovations Think back to where Connecticut was 20 years ago. A National Hockey League franchise had just left the…

New Crowdfunding and Crowdsourcing Ecosystem Helps Test Ideas, Hire…

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Logan: "Entrepreneurs can do more than offer rewards to backers." PLANTSVILLE: Two Connecticut entrepreneurs are taking on the crowd funding and…

Tech Company Hopes To Disrupt CT Real Estate Market

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FAIRFIELD: Connecticut has a new real estate company that is hoping that their expertise in software and digital marketing will allow them to disrupt…

New Haven's New Tech District Is Right Around The Corner

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By Mitchell Young NEW HAVEN: In December 2014, digital media entrepreneurs David Salinas and Peter Sena founders of Digital Surgeons a New Haven…

Nigerian National Pleads Guilty in E-Mail Scheme Defrauding Connecticut…

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NEW HAVEN: John H. Durham, United States Attorney for the District of Connecticut, and Patricia M. Ferrick, Special Agent in Charge of the New Haven…

Real Estate & Construction

Single-Family Home and Condo Prices Continue Upward Climb

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BOSTON: median single-family home price in Connecticut increased in March and the median condominium price followed a similar trajectory, according…

Tech Firm Relocates To Shelton Office Building

5 Research Drive Shelton
SHELTON, Dark Field Technologies has relocated their headquarters from Orange to Shelton, according to Jon Angel, president of Angel Commercial,…

Former Steel Company Industrial Property Sells

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HAMDEN: , A 19,000 square foot industrial property at 2115 State Street has been sold. The purchase price was not released but a recent listing for…

Women Commercial Realtor Group Cites 2018 Blue Ribbon Awards for Best Real…

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FARMINGTON: CREW-CT – The Real Estate Exchange, supports “advancing the achievements of women in commercial real estate,” the group named its winners…

CT Building Congress Names 2018 Project Team Awards Winners

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HARTFORD: The Connecticut Building Congress (CBC) has named the winners of the 2018 Project Team Awards (PTA). The Awards Banquet will be held on…

Branford’s Big Plans And Strong Relationships Yield Success For The Town

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By Terence Elton BRANFORD: “Make no little plans” was the advice of American architect and urban designer Daniel Burnham. His point was that in order…

New Haven Architects’ Design One of Six Selected for review for uberAIR…

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NEW HAVEN, LOS ANGELES: New Haven based Pickard Chilton working with Arup, Corgan, and The Beck Group was selected as one of six leading architecture…

Architect's Group Announce Connecticut Business Awards

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NEW HAVEN: AIA CT released the winners of its 2018 Business Awards. The organization says,this statewide award honors architects for solving business…

Waterfront Marina and Craft Brewery Moves Forward

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MILFORD: Dockside, a waterfront biergarten and craft brewery in Milford, has received a “green light” from several important agencies in the city…

Pizza Franchisor and Connecticut Entrepreneur To Bring “New York Style”…

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NEW YORK: Can New York style pizza get a slice of the New Haven and Connecticut market? The Artichoke Basille’s Pizza, franchise which says it is…

Government

Mr. Smith Wants to Go to Hartford

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OPINION: By Mitchell Young Or does he? Webster Bank Chairman and former CEO James Smith said on April 6 he wants to be Connecticut’s next Governor,…

Joel Schiavone: New Haven What Road To Where

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Joel Schiavone in New Haven magazine's first profile in 2007, on the Chaple Street that he layed the foundation for. Perhaps more than any single…

90's Era New Haven Developer Bob Mathews Indicted For EB 5 Visa "Scheme"…

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The estate of former New Haven Developer Bob Mathews, now under federal indictment. The home was priced for auction at $26.5 million, but has been…

Bridgeport Concert Venue Design Revealed

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BRIDGEPORT: Torpedoes or lawsuits be dammed that is the plan of Bridgeport’s Mayor Joe Ganim, and concert amphitheater developers Howard Saffan and…

CT Lawmakers Explore Sports Betting Ahead of SCOTUS Decision

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By: Keith M. Phaneuf and Clarice Silber ctmirror.org HARTFORD: House Democratic leaders are preparing to enact legislation this spring to launch…

Anti-Marijuana Organization Cites Potential Costs to Legalization

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HARTFORD: While Advocates for legalization of recreational use of Marijuana in Connecticut cite economic benefit to the state an anti-legalization…

Advocates for marijuana sales point to big economic boost

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By: Keith M. Phaneuf |ctmirror.org Advocates for legalizing recreational marijuana use in Connecticut — and taxing its sales — are hoping a holistic,…

Fairness to Governor May Come At Expense of Business

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Hartford: Governor Dannel Malloy thinks the Federal government has been so good to business that a little more tax coming their way is just fine.…

Internal Investigation, Lawsuits, Management Changes, A Failed Clinical Trial and New Competition, Heighten Speculation About the Future.

AlexionHQWinter2016NEW HAVEN: The Elm City’s new flagship company Alexion Pharmaceuticals [NASDAQ: ALXN] is finding itself under the microscope of lawyers, financial regulators, investment bankers and even bio-scientists as it reacts to significant financial and drug discovery events in the past 30 days.

In late November, the company announced an internal investigation into sales practices of its main revenue producing drug, Soliris. To date Soliris, with 2015 revenues of 2.5 billion has been the company’s sole financial driver.

The company’s stock trading was frozen for a short period as it declined to release its 10Q report on time. The company did file in early January stating there was no need for any material changes to its previous filings or restatements.  How that plays out with the lawsuits and whether it puts the issue to bed remains to be seen. Company analysts have said that whistleblower claims at big companies have become more common and part of the investment landscape. A 10Q report however, requires senior management to personally certify, in writing and under oath the accuracy of a company’s financial information.

What the company did release very quickly,surprising investors and analysts, were CEO David Hallal and CFO Vikhas Sinha who would have had to sign the 10Q.

Officially the company said Hallal was leaving for “personal” reasons and Sinha to pursue “other opportunities.” The investment news website Seeking Alpha however, argued that the pair was avoiding the filing responsibility under federal law [Sarbanes Oxley] to certify the report. It added that, “Alexion implied the executives departed due to the company having lost confidence in them.” 

Hallal took over from Alexion founder David Bell in April 2015, Bell remained as Chairman of the Board. An Alexion board member since July 2014

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New CEO Brennan

a former Astrazeneca [NYSE: AZN] CEO David Brennan, was chosen to “temporarily” take the position of CEO and headhunting firm Spencer Stuart was tapped to find a permanent replacement.  Former Honeywell International [NYSE:HON] CFO David Anderson was chosen as the company’s new CFO.  Brennan signed the 10Q certifying its statements.

Two investor class action lawsuits have already been filed against the company and several law firms across the country are seeking claimants. Building a class of disgruntled stockholders to join in, won’t likely prove a difficult task.

In early December, Alexion stock tumbled to $113 per share, its lowest level in three years. The company’s stock’s price however, had already come down along with many bioscience stocks from their 2016 highs, Alexion’s 52 week high was $193
per share. 

Two newly approved drugs are expected to fortify the company’s sales pipeline. The integration of its acquisition for $8.4 billion in June 2015 of Synageva of Lexington, MA, brought  the drug Kanuma and a previous acquisition in 2012 of Enobia of Montreal, Canada for $610 million brought the drug Strensiq.  Both drugs were approved by the FDA in late 2015 and like Soliris, treat rare diseases where there are no other current drug treatments.

Kanuma treats Lysosomal Acid Lipase Deficiency, [LAL Deficiency], a disease that prevents the body from adequately disposing of fatty acids. Leading to problems in the liver, spleen, and blood vessels. Stensiq treats Perinatal, Infantile and Juvenile-onset Hypophosphatasia (HPP),  an inherited rare metabolic bone disease that disrupts bone mineralization. Symptoms include weakening and softening of the bones that cause skeletal abnormalities. Hypophosphatasia affects an estimated 1 in 100,000 newborns.

The market for the two acquired drugs is estimated to have a potential of nearly $1.7 billion annually. They are off reportedly off to a slow start however. After a year plus on the market sales of the two are expected to be less than $200 million so far.

With new drugs coming on line, things started out pretty rosy in 2016 with the company moving into a new global corporate headquarters in downtown New Haven. Initially the company considered that 400-600 employees would occupy its new tower, 1,000 are said to be already there. The company has told the city to expect as many as 1,700 jobs could come to New Haven.

The original allegation about the Soliris sales practices was raised by a former employee of the company. 

The “listed” price of the drug for an annual treatment is currently approximately $450,000 per year, but the company offers a variety of methods to reduce that cost, including grants where necessary for patients. One explanation floated about the investigation revolved around how the company treated booking grants for the drug.

Alexion has been seeking new uses for Soliris and just received some bad news in that arena too.  Results from a Phase 2/3 trial of eculizumab (Soliris) showed “the drug failed to reach its primary endpoint for the prevention of delayed graft function in recipients of deceased donor kidneys.” There were no previously available treatments for this condition that can cause the loss of a transplanted kidney.

Competitors for Soliris have also begun to rise with their own clinical results coming in the most recent quarter. Alnylam Pharmaceuticals [Nasdaq:ALNY] of Cambridge, MA is a $3.5 billion market cap company that is developing a drug using RNA gene splitting technology, if successful their drug would compete directly against Soliris. The company said results from a Phase 1/2 trial when used with Soliris showed safety and improvements for patients and the need of less Soliris. That drug is still at least a Phase 3 trial success and FDA approvals down the road.

A smaller biotech Seattle’s Omeros  [NASDAQ: OMER] with less than a half billion dollar market cap just announced the FDA is signing off on the company’s plans for clinical development and manufacturing of another competing drug. The company is seeking accelerated approval, claiming it believes it has demonstrated “clinical advantages over Soliris.”

To qualify for accelerated approval, a drug must treat a serious condition and generally provide a ‘meaningful advantage’ over available therapies, the Omeros’ drug has already been tested in Phase 2 studies. 

The even smaller Akari Therapeutics [NASDAQ:AKTX] based in London with only a $87 million market cap is another competitor with a drug [Coversin] trying to close in on Soliris.  Akari’s drug is derived from a protein produced by ticks. Akari claims it targets the same body chemistry as Soliris and that side effects are minimal. Coversin is taken orally, while Soliris is infused weekly. Akari expects to move into Phase 3 trials of Coversin in 2017.

For several years Alexion has been
rumored to be a target for acquisition from a larger pharmaceutical company. The industry has been driven by consolidation fueled by an expected push back from government over pricing, and the need to obtain more scale to deal with the increasing costs of drug development. 

The acquisition target theory circulated on investment news media goes that most of the big fish are already taken in the “pharma space” or would receive a hostile response from governments in the US and Europe.

Alexion is by no means a giant, but with its approximate $30 billion market cap, and a currently captive market, it remains a potentially juicy target.

The alternate argument has been that big pharma companies don’t want orphan drugs that treat fewer than a few hundred thousand patients worldwide. Making the case harder, Alexion stock trading at 15 times sales was too overpriced for the “street.”

Be that as it may, the Streetinsider.com  a reliable investment news source reported in early December that Alexion “was approached by a large U.S.-based drug company interested in a merger, according to a person claiming to have knowledge of the matter. The name of the suitor wasn’t made available.” 

The site continued with, “a number of large U.S. and foreign players are known to be shopping for drugs large enough to move the needle on revenue, and slightly troubled companies like Alexion probably aren’t being ruled out.”

Alexion has not responded to the rumor.